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EUA Application LEARN MORE Medical Device 510K LEARN MORE Clinical Study LEARN MORE OTC Drug LEARN MORE The Advantage of Expertise The Hopkins MedTech
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Contact Us
Contact Us REGULATORY AND COMPLIANCE HELP WORLDWIDE Have questions about FDA compliance? Want help navigating the regulatory process in medical device
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EUA Application LEARN MORE Medical Device 510K LEARN MORE Clinical Study LEARN MORE OTC Drug LEARN MORE The Advantage of Expertise The Hopkins MedTech
Read original record ↗Our Company
Our Company The Hopkins MedTech Compliance helps medical device companies rapidly access the industry's best consultants, contractors, and candidates.
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Setup and Operation of US Based Sale Office
Setup and Operation of US Based Sale Office The US sales operations refers to the unit, role, activities and processes within the current China based
Read original record ↗Clinical study
Clinical study We perform usability testing、 human factors engineering and clinical trials on medical devices and point-of-care products to ensure the
Read original record ↗OTC Drug
OTC Drug Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance, as well as other regula
Read original record ↗Product Development
Product Development HMC will aid you throughout your product development strategy from day one. The goal is to provide data systems, advice, and solut
Read original record ↗Regulatory Strategy
Regulatory Strategy Each product has a certain regulatory strategy. With its expertise, HMC will provide you with an overview and detailed roadmap to
Read original record ↗Regulatory Submission
Regulatory Submission Submission before commercialization is the last but not least step in determining your success. Your next business goals and pla
Read original record ↗Post Market Surveillance
Post Market Surveillance Acceptance is not the end of your success, the next step is to maintain compliance with ISO 13485 and 21 CFR Part 820. You wi
Read original record ↗Facility Registration and Listing
Facility Registration and Listing Our services include assistance with Establishment registration and device listing, Any establishment involved in th
Read original record ↗FDA US Agent
FDA US Agent The appointment of an agent is a mandatory requirement for any foreign company wishing to market their products within the United States.
Read original record ↗Food and Dietary Supplements
Food and Dietary Supplements Our FDA consultancy can deliver support to enable you to market your food and dietary supplements. We can provide complet
Read original record ↗CGMP
CGMP cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, moni
Read original record ↗Medical Device 510K
Medical Device 510K We offer regulatory compliance services to Class I and Class II medical devices. Our services include ssistance with Establishment
Read original record ↗EUA Application
EUA Application We have a deep understanding of the urgency of developing emergency use products during pandemics and natural disasters. Our Emergency
Read original record ↗Marketing
Marketing Our marketing services for medical devices are focused on branding, promoting, and generating awareness and leads for medical device distrib
Read original record ↗Project Management
Project Management For your clinical trial to be successfulIn order for your clinical trial to be successful, it’s necessaryyou will need a profession
Read original record ↗Clinical Operation
Clinical Operation 1. STUDY START-UP With its expertise, HMC will help make your tests a success. We'll work out effective participantsign-up strategi
Read original record ↗Data Management
Data Management Data management in clinical trials is a necessary step to ensure accurate and reliable data are obtained. HMC's team of experts areis
Read original record ↗Biostatics
Biostatics Biostatistics in clinical research You will always receive real and timely data. Using advanced tools and techniques, HMC provides strategi
Read original record ↗Quality Assurance
Quality Assurance With this service package, you can rest assured that your implementation and monitoring processes are always up to the highest inter
Read original record ↗FDA
FDA As an industry leader, HMC will help you navigate FDA regulations and achieve compliance. We offer a wide range of capabilities such as product su
Read original record ↗IVDR
IVDR Compared to IVD, IVDR - (In vitro diagnostic regulation) is gaining more favor due to its transparent calculations and ability to maintain sustai
Read original record ↗Market Research
Market Research A worldwide network of partners and decades of data are the keys to HMC helping you explore your market. HMC has decades of data exper
Read original record ↗Post Market Compliance
Post Market Compliance From assisting with product development and initial submission preparation, HMC creates a corresponding support program to help
Read original record ↗Preclinical Research
Preclinical Research Did you know: All medical products need preclinical studies before testing on humans. As a leading consulting company in the medi
Read original record ↗Product Development
Product Development HMC will aid you throughout your product development strategy from day one. The goal is to provide data systems, advice, and solut
Read original record ↗Regulatory Strategy
Regulatory Strategy Each product has a certain regulatory strategy. With its expertise, HMC will provide you with an overview and detailed roadmap to
Read original record ↗Regulatory Submission
Regulatory Submission Submission before commercialization is the last but not least step in determining your success. Your next business goals and pla
Read original record ↗Post Market Surveillance
Post Market Surveillance Acceptance is not the end of your success, the next step is to maintain compliance with ISO 13485 and 21 CFR Part 820. You wi
Read original record ↗Clinical investigation.
Clinical investigation. Provide customers with a flexible approach to improve cycle times, limit costs, and reduce risk. We Specialize in the planning
Read original record ↗quality system
quality system Not only newly established companies but also large companies with many years of experience in the industry also face many difficulties
Read original record ↗Resources7 records
All Resources
All Resources Resources Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory i
Read original record ↗Intended Use Validation
All Resources by Alexis Ferrier / Feb 18, 2022 / Compliance, Consulting Group, Medical Devices, Regulatory, Standardization, Standards, Validation Med
Read original record ↗The FDA, CBD, and OTC Drugs
All Resources by Gabe Kadoo | Jan 25, 2022 | CBD, Compliance, Consulting Group, FDA, Guidance, QMS, Quality, Quality Systems, Regulatory, Standardizat
Read original record ↗510k Submissions for Sterile Devices
All Resources by Gabe Kadoo | Jan 13, 2022 | 510k, Compliance, Consulting Group, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardizat
Read original record ↗Determining the Right Regulatory Pathway for your Drug
All Resources by Alexis Ferrier | Nov 17, 2021 | Analytics, Compliance, Consulting Group, FDA, Guidance, Pharma, Pharmaceuticals, QMS, Quality, Qualit
Read original record ↗5 Reasons Why Internal Auditing is Important
All Resources by Alexis Ferrier | Dec 8, 2021 | Audits, Compliance, Consulting Group, FDA, QMS, Quality, Quality Systems, Regulatory, Requirements, St
Read original record ↗Join Us
All Resources Clinical Manager Hopkins MedTech Group DBA Hopkins MedTech Compliance is hiring a full-time Clinical Manager. Job Duties: ● Oversees the
Read original record ↗Industries5 records
IVDs
IVDs HMC experts will work with your team on a global scale to fast-track the commercialization of IVDs products. With our in-depth knowledge of curre
Read original record ↗Medical Devices
Medical Devices With our high-quality experts, HMC has helped many partners in the medical device industry develop products, helping them to meet inte
Read original record ↗Gene and Cell Therapies
Gene and Cell Therapies Your research will always be confidential and secure. Your biological therapy results will get to market faster. Our team of s
Read original record ↗Biopharma
Biopharma Biotechnology is developing at a rapid pace, FDA standards are becoming more strictly complex. Simplify your company's biotech development b
Read original record ↗Pharmaceuticals
Pharmaceuticals Do you have a new pharmaceutical product that you want to bring to market but don't know if the product is available? Are you worried
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Team
Team Team 1 Homer Wu, Ph.D. - Chief Scientist Over 25+ years of experience in professional services, Dr. Wu is a visionary, seasoned, and dynamic prof
Read original record ↗Extended records81 records
Projects overview
Each of our projects show professionalism and dedication. Up to now, more than 50 customers have successfully commercialized medical products thanks t
Read original record ↗In Vitro Diagnostics
HMC experts will work with your team on a global scale to fast-track the commercialization of IVDs products. With our in-depth knowledge of current re
Read original record ↗Regulatory strategy
By having a well-thought out strategy, you will minimize risks and quickly pass important milestones Learn more about Regulatory strategy.
Read original record ↗Product development
Corate with HMC for valuable advice and input. Let us accompany and assist you from the very beginning of your product development. Your steps will be
Read original record ↗Product Development
HMC will aid you throughout your product development strategy from day one. The goal is to provide data systems, advice, and solutions to accelerate t
Read original record ↗Clinical services
Project Management In order for your clinical trial to be successful, it’s necessary you will need a professional project administrator. We have the b
Read original record ↗Regulatory services
Regulatory Strategy Each product has a certain regulatory strategy. With its expertise, HMCwill provide you with an overview and detailed roadmap to h
Read original record ↗Market Research
Market Research A worldwide network of partners and decades of data are the keys to HMC helping you explore your market. HMC has decades of data exper
Read original record ↗Post-market services
Post Market Compliance From assisting with product development and initial submission preparation, HMC creates a corresponding support program to help
Read original record ↗Clinical investigation
Help your clinical trials quickly succeed, and eliminate unnecessary errors. We help you develop studies in a timely and effective manner. We also cre
Read original record ↗Submit
We stay up-to-date with the latest regulations to help get your product submitted in a correct, timely manner with minimal returns and loss of time. L
Read original record ↗Developing and ensuring the quality system
We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement the following: Compliant, Lea
Read original record ↗Post-market surveillance
We will carry out after-market monitoring activities and issue the necessary warnings. Making sure your business is sustainable. Learn more about Post
Read original record ↗Product Development
HMC will aid you throughout your product development strategy from day one. The goal is to provide data systems, advice, and solutions to accelerate t
Read original record ↗Regulatory Strategy
Each product has a certain regulatory strategy. With its expertise, HMC will provide you with an overview and detailed roadmap to help you visualize t
Read original record ↗Regulatory Submission
Submission before commercialization is the last but not least step in determining your success. Your next business goals and plans will be guaranteed
Read original record ↗Post Market Surveillance
Acceptance is not the end of your success, the next step is to maintain compliance with ISO 13485 and 21 CFR Part 820. You will need to participate in
Read original record ↗Post-market surveillance
We will carry out after-market monitoring activities and issue the necessary warnings. Make sure your business is sustainable. Bring your medical equi
Read original record ↗Developing and ensuring the quality system
We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement Compliant, Lean, Integrated,
Read original record ↗Submit
We stay up-to-date with the latest regulations to help get your product submitted in a timely, correct manner. Limited returns and loss of time. Learn
Read original record ↗Clinical investigation
Help your clinical trials quickly succeed, eliminating unnecessary errors. Helps you develop studies in a timely and effective manner. We also create
Read original record ↗Regulatory strategy
By having a well-thought out strategy, you will minimize risks and quickly pass important milestones Learn more about Regulatory strategy.
Read original record ↗Product Development
Collaborate with HMC for valuable advice and input. By letting us accompany you from the very beginning of product development, your steps will be sol
Read original record ↗Medical Devices
With our high-quality experts, HMC has helped many partners in the medical device industry develop products, helping them to meet international standa
Read original record ↗Gene & Cell Therapies
Your research will always be confidential and secure. Your biological therapy results will get to market faster. Our team of scientists have the lates
Read original record ↗Post-market surveillance
We will take steps to monitor after the market and report vigilance. Make it easier for you to commercialize your product. Kickstart your success by t
Read original record ↗Developing and ensuring the quality system
We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement Compliant, Lean, Integrated,
Read original record ↗Submit
We stay up-to-date with the latest regulations to help get your product submitted in a timely, correct manner. Limiting returns and loss of time. Lear
Read original record ↗Clinical investigation
HMC is your key partner in obtaining regulatory approval. We prepare a complete package of documents, shaping clinical trials to ensure success. In ad
Read original record ↗Pre-IND
This is an important step for you to shape your path to market. We'll help you prepare this entire important step, including formulating FDA questions
Read original record ↗Regulatory strategy
By having a well-thought out strategy, you will minimize risks and quickly pass important milestones Learn more about Regulatory strategy.
Read original record ↗Preclinical Research
We can support you through the entire preclinical research process. Compliance is guaranteed from initial animal model identification to final clinica
Read original record ↗Product development
Corate with HMC for valuable advice and input. By letting us accompany you from the very beginning of product development, your steps will be solid an
Read original record ↗Biopharma
Biotechnology is developing at a rapid pace, FDA standards are becoming more strictly complex. Simplify your company's biotech development by working
Read original record ↗Post-market surveillance
We will take steps to monitor after the market and report vigilance. Make it easier for you to commercialize your product. Save your cost and time by
Read original record ↗Developing and ensuring the quality system
We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement Compliant, Lean, Integrated,
Read original record ↗Submit
We stay up-to-date with the latest regulations to help get your product submitted in a timely, correct manner. Limited returns and loss of time. Learn
Read original record ↗Clinical investigation
HMC is your key partner in obtaining regulatory approval. We prepare a complete package of documents, shaping clinical trials to ensure success. In ad
Read original record ↗Pre-IND
This is an important step for you to shape your path to market. We'll help you prepare this entire important step, including formulating FDA questions
Read original record ↗Regulatory strategy
By having a well-thought out strategy, you will minimize risks and quickly pass important milestones Learn more about Regulatory strategy.
Read original record ↗Preclinical Research
We can support you through the entire preclinical research process. Compliance is guaranteed from initial animal model identification to final clinica
Read original record ↗Product development
Corate with HMC for valuable advice and input. By letting us accompany you from the very beginning of product development, your steps will be solid an
Read original record ↗Pharmaceuticals
Do you have a new pharmaceutical product that you want to bring to market but don't know if the product is available? Are you worried about meeting th
Read original record ↗Pharmacovigilance
HMC will continue to accompany you to develop your career. When you invest in a new project, we will continue to monitor the safety of your existing p
Read original record ↗Maintain the quality management system
We will maintain every aspect of your quality management system. Make sure your products are sustainable to standards and regulations.
Read original record ↗Quality system development
We have a proprietary methodology to establish a customized quality system tailored to you while meeting international standards. Not only does it hel
Read original record ↗Clinical investigation
HMC is your key partner in obtaining regulatory approval. We prepare a complete package of documents, shaping clinical trials to ensure success. In ad
Read original record ↗IND - Application for new drug registration before investigation
This is the step to help you shape the way to commercialize the product. We will help you arrange a pre-IND meeting with the FDA and prepare all the d
Read original record ↗Regulatory strategy
With our solid experience, we will help you create a suitable plan to lead to success. HMC's team of scientists will help you categorize products, def
Read original record ↗Preclinical Research
We can support you through the entire preclinical research process. Compliance is guaranteed from initial animal model identification to final clinica
Read original record ↗Drug development
HMC has a full range of resources, including collaborative labs and in-house engineers to accompany you from the very first steps of drug development.
Read original record ↗EUA Application
We have a deep understanding of the urgency of developing emergency use products during pandemics and natural disasters. Our Emergency Use Authorizati
Read original record ↗Medical Device 510(k)
We offer regulatory compliance services to Class I and Class II medical devices. Our services include ssistance with Establishment registration and de
Read original record ↗Clinical study
We perform usability testing、 human factors engineering and clinical trials on medical devices and point-of-care products to ensure they go to market
Read original record ↗OTC Drug
Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance, as well as other regulatory comp
Read original record ↗Facility Registration and Listing
Our services include assistance with Establishment registration and device listing, Any establishment involved in the production, importation, reproce
Read original record ↗FDA US Agent
The appointment of an agent is a mandatory requirement for any foreign company wishing to market their products within the United States. We can act a
Read original record ↗Food and Dietary Supplements
Our FDA consultancy can deliver support to enable you to market your food and dietary supplements. We can provide complete assistance for understandin
Read original record ↗CGMP
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, monitorin
Read original record ↗Marketing
Our marketing services for medical devices are focused on branding, promoting, and generating awareness and leads for medical device distributors and
Read original record ↗US Sales Office
The US sales operations refers to the unit, role, activities and processes within the current China based sales organization that support, enable, and
Read original record ↗Original website record 93
The Hopkins MedTech Compliance helps medical device companies rapidly access the industry's best consultants, contractors, and candidates. Our resourc
Read original record ↗Original contact record
Headquarters: Phone: 800 320-1438 E-mail:
Read original record ↗Jennifer Stanford - Director of Clinical Operation
Over 25+ years of nursing and leadership experience in both clinical research and critical care, she has served in clinical operation director role in
Read original record ↗Homer Wu, Ph.D. - Chief Scientist
Over 25+ years of experience in professional services, Dr. Wu is a visionary, seasoned, and dynamic professional, offering in-depth scientific, regula
Read original record ↗Project Management
For your clinical trial to be successfulIn order for your clinical trial to be successful, it’s necessaryyou will need a professional project administ
Read original record ↗Clinical Operations
1. STUDY START-UP With its expertise, HMC will help make your tests a success. We'll work out effective participantsign-up strategies, quick processes
Read original record ↗Data Management
Data management in clinical trials is a necessary step to ensure accurate and reliable data are obtained. HMC's team of experts areis always qualified
Read original record ↗Biostatistics
Biostatistics in clinical research You will always receive real and timely data. Using advanced tools and techniques, HMC provides strategic services:
Read original record ↗Quality Assurance
With this service package, you can rest assured that your implementation and monitoring processes are always up to the highest international standards
Read original record ↗FDA Regulatory Consulting
As an industry leader, HMC will help you navigate FDA regulations and achieve compliance. We offer a wide range of capabilities such as product submis
Read original record ↗European IVDR
Compared to IVD, IVDR - (In vitro diagnostic regulation) is gaining more favor due to its transparent calculations and ability to maintain sustainabil
Read original record ↗Market Research
A worldwide network of partners and decades of data are the keys to HMC helping you explore your market. HMC has decades of data experience and a worl
Read original record ↗Post Market Compliance
From assisting with product development and initial submission preparation, HMC creates a corresponding support program to help you bypass warning let
Read original record ↗INTENDED USE VALIDATION
Resource Center Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the li
Read original record ↗Clinical investigation.
Provide customers with a flexible approach to improve cycle times, limit costs, and reduce risk. We Specialize in the planning, management, execution,
Read original record ↗Quality Systems
Not only newly established companies but also large companies with many years of experience in the industry also face many difficulties to overcome th
Read original record ↗Preclinical Research
Did you know: All medical products need preclinical studies before testing on humans. As a leading consulting company in the medical and health field,
Read original record ↗Qian Cheng, Ph.D. - Chief Biostatistician
With less than 10% of investigational products making it to post-marketing surveillance during clinical trials, it is imperative to build a statistica
Read original record ↗Andrew Wayland - Director of Business Development
Master of Business Administration MBA Clinical Research and Healthcare Administrator, Advance innovative discoveries for the treatment of human diseas
Read original record ↗Wendy Zhou, Ph.D. - Director of Laboratory Services
With over 25+ years of strong experience in the pharmaceutical and medical device clinical research industry, Dr. Zhou has thorough and demonstrated k
Read original record ↗Test record1 records
Component records9 records
OTC Drug
OTC Drug
Read original record ↗Clinical Study
Clinical Study
Read original record ↗Medical Device 510K
Medical Device 510K
Read original record ↗EUA Application
EUA Application
Read original record ↗Client First
Client First
Read original record ↗A Holistic Approach
A Holistic Approach
Read original record ↗Partnership
Partnership
Read original record ↗Hopkins MedTech Compliance is truly an industry expert and has patiently worked with us by assisting us in gaining a better understanding of FDA guidance and requirements.... This has dramatically improved our confidence in this area. They also assisted u
Hopkins MedTech Compliance is truly an industry expert and has patiently worked with us by assisting us in gaining a better understanding of FDA guida
Read original record ↗It’s hard to find a company you can trust. Hopkins MedTech Compliance was recommended to me by a friend, and now I know why – the quality of service I received was outstanding. We now have a world-class quality system.
It’s hard to find a company you can trust. Hopkins MedTech Compliance was recommended to me by a friend, and now I know why – the quality of service I
Read original record ↗