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
- 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
- About Regulatory Affairs And more ...
- The FDA eSTAR Program: should or must you take part?
- Instructions for Use for Medical Devices and IVDs in the EU
- Medical Device Advertising in Germany and the EU – What is Allowed and What Isn’t
- Substance-Based Medical Devices
- System Architecture
- Digital Health Applications Ordinance
- Conformity Assessment
- Harmonized Standards
- Technical Documentation
- CE Marking
- Device group
- How You Can Meet the Data Security and Protection Requirements for Digital Health Applications
- Privacy Shield Agreement
- Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416
- Marketing Personal Protective Equipment (PPE)
- The Medical Device File: What You Don’t Have to Include in This File
- Measuring Function
- Class 1 Medical Devices
- Accessories for Medical Devices
- Declaration of Conformity
- Design Change
- Essential Requirements
- GDPR
- EUDAMED
- Free Sales Certificates
- Harmonized Standards
- Laboratory Developed Tests
- MEDDEV Documents
- Notified bodies
- Periodic Safety Update Report PSUR
- Post-Market Surveillance
- Systems & Procedure Packs
- Unique Device Identification
- Physiological processes
- 3D Printing in Medicine: Avoiding Regulatory Traps
- Regulatory Update
- State of the Art: It’s Worse Than You Think
- The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?
- Medical Device Consultant
- Product Liability
- Code Verifier
- EU Declaration of Conformity
- From a Regulatory Perspective: What Is a Child?
- DVPMG
- Impact of EU Case Law on Standard Harmonization
- MDCG 2020-6: Clinical Data Requirements for Legacy Devices
- Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim
- Companion Diagnostics (CDx)
- What Constitutes the Lifetime of a Medical Device in the EU?
- How Do You Write a Good Definition?
- Combination products
- Radio Equipment Directive (RED)
- EU Data Act
- The Health Insurance Portability and Accountability Act
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Quality Management Systems for Medical Devices & ISO 13485
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Medical Device Software & IEC 62304
- 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
- Medical Device Software and more
- How to Build a Successful Development Team
- IT-Security
- Artificial Intelligence
- Parameterization
- Creating standard operating procedures for QM
- Validation of Machine Learning Libraries
- Anonymization and Pseudonymization
- IEC 60601-4-5
- CVSS – Common Vulnerability Scoring System
- Medical grade software
- ISO 27034 on Application Security
- ISO 27001
- Transfer Learning in Medical Devices
- ISO/IEC TR 29119-11 on Testing AI/ML Software?
- ISO/IEC TR 29119-6 on software testing
- Code Generation
- IEC 81001-5-1: The standard for secure health software
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Risk Management & ISO 14971
- 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
- And more...
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Usability & IEC 62366
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Medical Electrical Equipment & IEC 60601
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Clinical Evaluation
- MDCG 2020-5
- The Clinical Evaluation Literature Search
- ClinicalTrials Search Mask
- MDCG 2020-6: Data Requirements for Legacy Devices
- Clinical evaluation of software
- Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs
- Insurance for Clinical Investigations
- Clinical Evaluation of Medical Products
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Biocompatibility
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AI & Machine Learning
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More interesting topics...
- 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
- Other Topics and more
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