Resources
The following is a list of some great resources to for 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
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
Organizations local to Southern California – these organizations are great for in-person events and often offer virtual events
- SDRAN – San Diego Regulatory Affairs Network
- Offerings include classes, lectures, networking and mentoring
- OCRA – Orange County Regulatory Affairs Discussion Group
- Offerings include classes, lectures, seminars and networking
- Device Alliance – Professional network serving Southern California
- Offerings include seminars, networking and mentoring
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
Software Validation Guidance Documents
- Computer Software Assurance for Production and Quality System Software – Draft Guidance for Industry and Food and Drug Administration Staff – September 13, 2022
- CDRH Learn Webinar on this guidance document presented October 27, 2022
- Computerized Systems Used in Clinical Investigations – Guidance for Industry – May 2007
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers – Guidance for Industry – March 2023
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)