Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Medical device companies |
| Work | Quality-system documentation, assessment and action planning |
| Rules and standards | FDA QMSR, 21 CFR Part 820 and ISO 13485, as applicable |
The FDA Quality Management System Regulation (QMSR) took effect on February 2, 2026. Read the FDA QMSR requirements.
HMC supports quality management system (QMS) documentation and implementation planning.
The scope is agreed for the product, company structure and applicable requirements.
Medical equipment
Compliance Options:
● 21 CFR 820
● 21 CFR 801
● 21 CFR 803
● 21 CFR Part 11
● ISO 13485
● ISO 14971
● IEC 62304
● EU MDR / In Vitro Diagnostic Medical Devices Regulation (IVDR)
Medicine
Compliance Options:
● 21 CFR 210
● 21 CFR 211
● ISO 9001
Biological
Compliance Options:
● 21 CFR 600
● ISO 9001
Combination products
Compliance Options:
● 21 CFR 210
● 21 CFR 211
● 21 CFR 820
● 21 CFR 803
● 21 CFR Part 11
● ISO 13485
● ISO 14971
● IEC 62304
● EU MDR / IVDR
Contact HMC to discuss the requirements for your product.
Our Optimized WorkflowExpertise
Quality system work may include a master plan, assessment plan, action plan, validation report and supporting documents.
Check quality
Audit scope and reporting requirements are agreed before work begins.
Design control
Design control support includes design requirements, validation and device master record (DMR) documentation.
Supplier quality
Supplier quality work includes due diligence and documented assessment findings.
Service information adapted from the original source ↗.
Read the original website record