ISO 13485 vs. CFR Part 820
A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
Read more
Sierra Labs Blog
Recent Posts
Topics
- FDA (42)
- QMS (31)
- Compliance (28)
- Medical Device (27)
- Medical Device Company (26)
- SaMD (26)
- Data Security (17)
- Regulations (17)
- 21 CFR Part 820 (15)
- Medical Devices (15)
- ISO (14)
- FDA Approval (13)
- Agile (12)
- Data Privacy (12)
- FDA Regulation (12)
- ISO 13485 (11)
- SaMD Development (11)
- CFR Part 820 (10)
- Data Requirements (10)
- Document Controls (10)
- FDA Pre-Sub (10)
- Health Technology (10)
- Regulatory Pathway (10)
- AI (9)
- Documentation (9)
- GxP Cloud (9)
- Quality System Regulation (9)
- Technology (9)
- Validated Cloud (9)
- risk (9)
- Cloud (8)
- FDA Audit (8)
- GxP (8)
- Health Data (8)
- ISO 13485:2016 (8)
- ISO 14971 (8)
- Manufacturing (8)
- PHI (8)
- Personal Health Information (8)
- Conformity (7)
- Healthcare (7)
- Life Science QMS (7)
- Medical Solutions (7)
- Product Development (7)
- Regulatory Strategy (7)
- SaMD QMS (7)
- Software Requirement Specification (7)
- Standards (7)
- 21 CFR (6)
- Quality Management System (6)
- Quality Processes (6)
- Regulatory Roadmap (6)
- eHealth (6)
- 21 CFR Part 11 (5)
- Artificial Intelligence (5)
- CAPA (5)
- COVID19 (5)
- Design Controls (5)
- Digital Health (5)
- Health Tech (5)
- Jira Cloud (5)
- Jira QMS (5)
- New Drugs (5)
- QMS healthcare (5)
- Sierra QMS (5)
- training management (5)
- Automation (4)
- Biopharma (4)
- Business Associates (4)
- Communication (4)
- Covered Entities (4)
- Data Integrity (4)
- Development Change (4)
- Drug Approval (4)
- GAMP5 (4)
- HIPAA (4)
- HIPAA Compliance (4)
- Health Applications (4)
- Integrated QMS (4)
- Medical Device Startups (4)
- Pre-Submission (4)
- Product Lifecycle (4)
- Quality Roadmap (4)
- Recall (4)
- Regulatory Approach (4)
- Remote Work (4)
- Scale-ups (4)
- Software (4)
- Streamline Workflows (4)
- document management (4)
- ePHI (4)
- 510(k) (3)
- COVID-19 Solution (3)
- Case Study (3)
- Compliance Process (3)
- Cybersecurity (3)
- DTx (3)
- Design Verification (3)
- Document Automation Tools (3)
- FDA Standard (3)
- GAMP (3)
- HIPAA Checklist (3)
- Hardware-based (3)
- IEC 62304 (3)
- ISPE (3)
- Iterative Process (3)
- Life Science (3)
- Medical Technology (3)
- Pharma (3)
- Predicate Device (3)
- Product Requirements Document (3)
- QMS for SaMD Startups (3)
- Risk Management (3)
- SOC (3)
- SOC 2 (3)
- SOP (3)
- SaMD Startups (3)
- Software Development (3)
- Telecare (3)
- Telehealth (3)
- eQMS (3)
- AWS (2)
- Audit Trails (2)
- CDER (2)
- CE Marking (2)
- CFR (2)
- Center for Biologics Evaluation and Research (2)
- Center for Drug Evaluation and Research (2)
- Clinical Evaluation (2)
- Corrective Action Preventive Action (2)
- Document Automation (2)
- Document Control (2)
- Documentation Automation (2)
- Electronic Records (2)
- GMP (2)
- General Controls (2)
- HITRUST (2)
- HITRUST CSF (2)
- ML (2)
- Machine Learning (2)
- New Draft (2)
- Pharmaceutical (2)
- Pre-market approval (2)
- QS (2)
- Risk Classification (2)
- Risk Managment (2)
- Sierra Policies (2)
- Sierra Services (2)
- Standard Operating Procedure (2)
- fda submission (2)
- mHealth Wearables (2)
- rta (2)
- software as medical device (2)
- 21 cfr 807 (1)
- 513G (1)
- AAMI TIR45 (1)
- AICPA (1)
- ANVISA (1)
- Agência Nacional de Vigilância Sanitária (1)
- Amazon Web Services (1)
- Analytical Validation (1)
- Annex 11 (1)
- Australian Therapeutic Goods Administration (1)
- BLA (1)
- Backlog (1)
- Biologic Approval (1)
- Business Goals (1)
- CGMP (1)
- Cannabis (1)
- Cannabis Compliance (1)
- Change Control (1)
- Client Reference (1)
- Clinical Development (1)
- Clinical Validation (1)
- Code Reviews (1)
- Conference (1)
- Coronavirus (1)
- Current Good Manufacturing Practice (1)
- Customer Complaint (1)
- Data Transfer (1)
- Design Changes (1)
- Design History File (1)
- Design Transfer (1)
- Development Team (1)
- Device Classification (1)
- Device Software Functions (1)
- Document Publishing (1)
- Drug Manufacturing (1)
- EUA (1)
- Electronic Signatures (1)
- Emergency Use Authorization (1)
- Enforcement Discretion (1)
- Engineering (1)
- Ethos Automated System (1)
- FDA Draft (1)
- HHS (1)
- Hand Sanitizer (1)
- Hardware Development (1)
- IEC (1)
- IEC 60601 (1)
- IEC 60601:1 (1)
- IEC 62366 (1)
- IFU (1)
- IND (1)
- ISO 13485: 2003 (1)
- ISO90003:2004 (1)
- Intellectual Property (1)
- International Electrotechnical Commission (1)
- International Organization for Standardization (1)
- Jira Server (1)
- Key Terms (1)
- Labeling (1)
- Liability (1)
- MDSAP (1)
- METRC (1)
- MHLW/PMDA (1)
- Management Controls (1)
- Masks (1)
- Medical Device Single Audit Program (1)
- Medical Marijuana (1)
- Ministry of Health, Labour and Welfare (1)
- Myths (1)
- New Approach Directives (1)
- New Drug Application (1)
- Nonconformity (1)
- PCCP (1)
- PRD (1)
- Pandemic (1)
- Part 11 (1)
- Part 820.30 (1)
- Performance Tests (1)
- Preliminary Screening (1)
- Project Deliverables (1)
- Project Timeline (1)
- QA/RA (1)
- QMSR (1)
- Regulatory Options (1)
- SRS (1)
- SaMD Risk Classification (1)
- SaMD for QMS (1)
- SiMD (1)
- Software Architecture (1)
- Sprints (1)
- Substantial Equivalence (1)
- TGA (1)
- TSC (1)
- Trust Services Criteria (1)
- Valid Clinical Association (1)
- Validation Testing (1)
- Waterfall Method (1)
- Webinar (1)
- Workflow Transitions (1)
- abbreviated 510(k) (1)
- administrative evaluation (1)
- medical device quality management system (1)
- paperless quality processes (1)
- qms Samd (1)
- qms cloud (1)
- refuse-to-accept (1)
- rta letter (1)
- special 510(k) (1)
- traditional 510(k) (1)
Subscribe Here
-
- © 2022 Sierra Labs, Inc.
- Contact Us
- hello@sierralabs.com
- 3415 S. Sepulveda Blvd.
Suite 1000
Los Angeles, CA 90034 - (310) 437-8010
- Products
- Company
- About Us