Quick access to all of our articles:
FDA
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MDR / IVDR
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International
- International Medical Device Authorizations: 5 Steps to New Markets
- INMETRO and ANATEL Certification
- Switzerland: What Medical Device Manufacturers Should Now Be Aware Of
- Brexit: How you can still sell your medical devices in the UK
- Market Access of Medical Devices in Japan
- Market Access of Medical Devices in Brazil
- Market Access of Medical Devices Saudi Arabia
- Market Access of Medical Devices in China
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Regulatory Affairs
- FDA registration: The same procedure as every year!
- Clinical affairs manager in the medical device industry
- Clinical evaluation: you can easily avoid these misconceptions and mistakes
- Remediation: When things hit the fan
- The Clinical Evaluation Plan
- General laboratory equipment: What manufacturers and laboratories need to know to avoid problems and unnecessary expense
- Developing a regulatory strategy: 6 good reasons
- MDCG 2023-4 on combinations of MDSW and hardware
- Post-Market Clinical Follow-up: Best Practices for PMCF
- Predicate device & substantial equivalence
- Medicinal product or (substance-based) medical device?
- EU Battery Regulation: What medical device manufacturers need to know
- Sampling Kits
- South Korea
- Clinical Data for Medical Devices
- RIMS: Future or anchoring in the past?
- Regulatory Intelligence - a core task of Regulatory Affairs?
- Differences between the IVDR and IVDD
- The 510(k) clearance
- Clinical endpoints
- Special authorizations for medical devices: Last resort for manufacturers?
- No animal testing to prove biocompatibility
- Digitalization of notified bodies
- Devices without an intended medical purpose - Annex XVI devices
- Regulations as Code: The End of Regulations as We know it
- medical devices turkey
- PMS data: when do you need ethics committee
- Recycling and Disposal of Medical Devices
- Verification versus Validation
- Intended Use Description
- Medical Device Directive
- Classification
- Glossary for medical device manufacturers
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Quality Management Systems for Medical Devices & ISO 13485
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Medical Device Software & IEC 62304
- SBOM: Software Bill of Materials
- IT security for “legacy devices”
- Development process: Lean and compliant with standards
- Software components
- Black box testing
- Software integration tests & integration strategy
- Software as Medical Device
- Software Lifecycle
- Safety Classes & Level of Concern
- SOUP and OTS
- Medical Apps
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Risk Management & ISO 14971
- Let service providers take care of risk management?
- Risk management plan: The most important advantages
- PMS trend analysis - a complex issue where you cannot fail
- DIN EN IEC 80001-1
- Risk mitigation through information?
- Risk management errors
- Risk management report: There are options
- Life Cycle Risk Management
- Update 14971:2012
- Harm and Severity
- Hazard and Hazardous Situation
- Risk Acceptance
- Third edition of ISO 14971
- ISO/IEC/IEEE 15289
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Usability & IEC 62366
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Medical Electrical Equipment & IEC 60601
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Clinical Evaluation
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Biocompatibility
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AI & Machine Learning
- Clinical investigations be avoided with artificial intelligence?
- Regulatory Requirements for Medical Devices with Machine Learning
- Computer-Based Modeling & Simulation
- Autonomous Systems
- The Interpretability of AI: A Look into the Black Box of Machine Learning
- Why VDE-AR-E 2842-61 (Trustworthy AI Systems) Doesn’t Just Apply to Development
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More interesting topics...
- PDMS (Patient Data Management System): What you should consider from a regulatory perspective
- Phantoms in medical technology
- Risk management in hospitals and at other operators
- PMCF studies: three types to be distinguished
- PFAS ban
- ASCA Accreditation Scheme for Conformity Assessment
- Maintenance and service of medical devices
- Class-1-Software
- The Machinery Directive
- Digital Transformation
- Classification: 8 Tips for Precise Pigeonholing
- FHIR: Three Steps to Your Own Profile
- Medical Devices as Disability Aids
- Regulatory Science
- Health Care Facilities
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