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.
If we can answer any questions, please reach out!
Select an Area of Interest
Medical Device Training & Education
Some 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 – Medical Device Regulatory Fundamentals
- Emergo – Top level information about all world markets
- Greenlight Guru – Free webinars and white papers
- Intertek – white papers, webinars and more in-depth training
- RAPS – 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 Professional Society
- SDRAN – San Diego Regulatory Affairs Network
- TOPRA – The Organisation for Professionals in Regulatory Affairs
Clinical Laboratory
- Clinical Laboratory Improvement Amendments (CLIA)
- CLIA Waived Test List
- How to Apply for a CLIA Certificate, Including International Laboratories
- Clinical Laboratory Improvement Amendments (CLIA) State Agency Contacts
- CLIA Certification Fee Schedule
- CLIA Complexity Categorization Tool
- List of Approved Accreditation Organizations
- CAP – How to Validate a New Test 2010
- FDA Draft Guidance – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
- FDA Draft Guidance – FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)
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
- OECD Best Practice Guidelines for Biological Repository Center
- 21 CFR Part 50 Protection of Human Subjects
- 21 CFR Part 54 Financial Disclosure by Clinical Investigators
- 21 CFR Part 56 Institutional Review Boards
- ICH Good Clinical Practice (GCP)
- 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)
