Resources
The following is a list of some great resources to learn more about medical device training and education, quality and regulatory associations, clinical laboratories, specimen collection, good laboratory practices, and more.
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Select an Area of Interest
Medical Device Training & Education
Great resources to learn more about common quality and regulatory topics:
- BSI Learn Central – Free webinars for introductory information and paid trainings for more in-depth learning
- CDRH Learn – Free medical device regulatory fundamentals directly from FDA
- Emergo – Free top level information about all world markets
- Greenlight Guru – Free webinars and white papers
- Regulatory Affairs Professionals Society – Paid certification and credential programs, textbooks and some free webinars
Quality and Regulatory Associations
Medical device trade & professional associations offer networking, education, and perks like discounted purchasing groups:
- AdvaMed – Advanced Medical Technology Association
- ASQ – America Society for Quality
- AAMI – Association for the Advancement of Medical Instrumentation
- BIOCOM – Biocom Life Science Association
- CLSA – California Life Sciences Association
- CLSI – Clinical Laboratory Standards Institute
- Device Alliance – Serving Southern California
- MassMEDIC – Massachusetts Medical Device Industry Council
- Medical Alley Association – Serving Minneapolis and St. Paul
- MichBio – Serving Michigan’s biotech industry
- OCRA – Orange County Regulatory Affairs Discussion Group
- RAPS – Regulatory Affairs Professionals Society
- SDRAN – San Diego Regulatory Affairs Network
- SQA – Society of Quality Assurance
- TOPRA – The Organisation for Professionals in Regulatory Affairs
Clinical Laboratory Resources
- FDA Final Rule on Laboratory Developed Tests (LDTs)
- Clinical Laboratory Improvement Amendments (CLIA)
- How to Apply for a CLIA Certificate, Including International Laboratories
- Clinical Laboratory Improvement Amendments (CLIA) State Agency Contacts
- CLIA Complexity Categorization Tool
- List of Approved Accreditation Organizations
IRB and Specimen Collection
- Human Subjects Training
- FDA Guidance for Sponsors, Institutional Review Board, Clinical Investigators and FDA Staff – Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
- Developing a Simplified Consent Form for Biobanking
- 21 CFR Part 50 Protection of Human Subjects
- 21 CFR Part 54 Financial Disclosure by Clinical Investigators
- 21 CFR Part 56 Institutional Review Boards
- De-identification and Re-identification
Good Laboratory Practice
- Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP
- EPA Good Laboratory Practice Inspection Manual
- 40 CFR Part 160 (EPA GLP Regulations)
- 21 CFR Part 58 (FDA GLP Regulations)
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
- Guidance for Industry – Good Laboratory Practices Questions and Answers
- The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers – Draft Guidance for Industry and Food and Drug Administration Staff (withdrawn 10/2018)