Here are our latest Articles:
- IVD Software
- Risk management in hospitals and at other operators
- Remediation: When things hit the fan
- The Clinical Evaluation Plan
- Pass an FDA inspection with confidence
- The end of 21 CFR part 820?
- Product Liability: Medical Device Manufacturers Pay Attention
- ISO 10993-17: What the standard has changed and now requires from manufacturers
- General laboratory equipment: What manufacturers and laboratories need to know to avoid problems and unnecessary expense
- In-vitro Diagnostic Device Regulation (IVDR)
- Transitional provisions of the IVDR
- EU Data Act: Hand over the data!
- Let service providers take care of risk management?
- The most frequently asked questions about the quality management system
- SBOM: Software Bill of Materials
- DAkkS: What's behind the outrage about ISO 13485?
- Phantoms in medical technology
- IT security for “legacy devices”
- Digitalization of the production
- Developing a regulatory strategy: 6 good reasons
- Risk management plan: The most important advantages
- 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 from a Regulatory Perspective
- South Korea: An interesting market for medical device manufacturers
- Clinical evidence: How to prove it
- Clinical Data for Medical Devices
- Harmonized Standards
- Design Change: Examples and Requirements
- PMCF studies: three types to be distinguished
- RIMS: Future or anchoring in the past?
- PFAS ban: You must act immediately!
- Regulatory Intelligence - a core task of Regulatory Affairs?
- ASCA Accreditation Scheme for Conformity Assessment
- PMS trend analysis - a complex issue where you cannot fail
- DIN EN IEC 80001-1:2023
- Differences between the IVDR and IVDD
- Risk mitigation through information?
- Development process: Lean and compliant with standards
- Develop software components compliant with IEC 62304 and FDA
- FDA: The 510(k) clearance (Premarket Notification)
- The 7 most common risk management errors
- Clinical endpoints: Why they are important
- Functional safety for medical devices
- Use Scenario - User Story - User Task: Finally understandable
- Risk management report: There are options
- Special authorizations for medical devices: Last resort for manufacturers?
- Maintenance and service of medical devices
- FDA Human Factors Guidances
- No animal testing to prove biocompatibility
- 7 steps to the DiGA directory
- Black box testing
- Software integration tests & integration strategy
- Digitalization of notified bodies
- The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?
- Class-1-Software
- Devices without an intended medical purpose - Annex XVI devices
- Regulations as Code: The End of Regulations as We know it
- Medical devices in Turkey: Regulatory requirements
- PMS data: Do you need to involve an ethics committee when collecting data?
- 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
- Self-tests and Near-patient Tests: What EU Law Says
- Threat Modeling – An Introduction
- Performing FDA Recalls Correctly
- EU HTA Regulation 2021/2282 – What the Harmonized Health Technology Assessment Will Bring
- Process FMEA (pFMEA): How to Systematically Identify Process Risks
- Medical devices for Ukraine
- How to Build a Successful Development Team
- The Health Insurance Portability and Accountability Act
- Avoid the Five Most Common Mistakes When Submitting a Premarket Notification (510(k))
- MDCG 2020-6: Clinical Data Requirements for Legacy Devices
- What Manufacturers Need to Know about Legacy
- Medical Device Sustainability
- Radio Equipment Directive (RED) for networked medical devices in the EU
- Combination products: Applicable law and regulatory requirements
- 21 CFR part 820: FDA requirements for quality management systems
- Classification and registration pathways of medical devices and IVDs in the U.S.
- Design Thinking: More Usability and Better Medical Devices
- Level of Concern: What the FDA wants to achieve with it
- Abbreviated 510(k) - When the abbreviation is allowed
- How Do You Write a Good Definition?
- Electronic instructions for use for medical devices (EU law)
- What Constitutes the Lifetime of a Medical Device in the EU?
- Telematics Infrastructure
- MDR / IVDR – “Person Responsible for Regulatory Compliance” (PRRC)
- Companion Diagnostics (CDx) – Strictly Monitored In Vitro Diagnostic Devices
- FHIR: Three Steps to Your Own Profile
- Six steps to market authorization for medical devices in Germany and the EU
- Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim
- Digital Transformation
- IEC 81001-5-1: The standard for secure health software
- Classification: 8 Tips for Precise Pigeonholing
- “James Elliott” and “Global Garden” Impact of EU Case Law on Standard Harmonization
- IEC 62366-1:2015 new information on the usability standard
- Classification of in-vitro diagnostic medical devices: how to avoid too high a classification
- The Machinery Directive: Which Parts Apply to Medical Devices?
- IOP Governance-Verordnung (GIGV) - What Manufacturers Can Expect
- Code Generation: The Magic Formula for Faster and Better Code?
- Does ISO/IEC TR 29119-6 on software testing help in agile projects too?
- Importers: What Do the MDR and IVDR Actually Demand?
- DVPMG – Law on Digital Modernisation of Healthcare and Nursing Care
- From a Regulatory Perspective: What Is a Child?
- IEC 60601-1-8: 12 steps back to conformity
- ISO/IEC/IEEE 15289: Clarity at Last for Software Documentation?
- Switzerland: What Medical Device Manufacturers Should Now Be Aware Of
- EN ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
- EU Declaration of Conformity
- ISO 20417:2021 – Finally Some Clear Requirements for Accompanying Information
- IEC 60601-1 Essential Performance in Medical Devices
- Do You Need to Be Aware of ISO/IEC TR 29119-11 on Testing AI/ML Software?
- Substance-Based Medical Devices: What You Have to Do to Be Able to Continue Marketing Your Existing Devices Under The MDR
- Cytotoxicity Testing According to EN ISO 10993-5: Avoiding Pitfalls When Choosing a Laboratory
- Code Verifier: Is A Smartphone Enough?
- INMETRO and ANATEL Certification: Requirements for Authorization in Brazil?
- IEC 60601-1-2 (Electromagnetic Compatibility of Medical Devices): Pay Attention to the New Edition!
- Brexit: How you can still sell your medical devices in the UK
- Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs: The 6 Questions Your Statistician Must Answer
- Medical Devices as Disability Aids: An Additional Source of Revenue?
- Management Reviews: 5 Reasons Why Bosses Should Love Them
- Clinical evaluation of software: Three proofs of conformity
- Corrective and Preventive Actions
- Transfer Learning in Medical Devices: Regulatory Recklessness or an Ethical Necessity?
- Recycling and Disposal of Medical Devices: How “Trash” Can Give You a Market Advantage
- Medical Device Consultant – Only A German Concept?
- ISO 27034 on Application Security: Reading It = A Waste of Time?
- Regulatory Science: Europe is Flying Blind
- Safety Assurance Cases: A Way to Shorten Painful Discussions with Auditors
- ISO 27001: IT Security Management for all Medical Device Manufacturers?
- MDCG 2020-5: The End of the Equivalence Route for Clinical Evaluations?
- Market Access of Medical Devices in Brazil
- Developing the Wrong Devices with User-Centered Design
- International Medical Device Authorizations: 5 Steps to New Markets
- Glossary for medical device manufacturers
- The Clinical Evaluation Literature Search: 6 Tips to Save You Time and Stress
- Levels of User Interface Design
- The Medical Device File: What You Don’t Have to Include in This File
- In Vitro Diagnostic Medical Device Performance Evaluation: 8 Steps to Conformity
- State of the Art: It’s Worse Than You Think
- User Interface Design What We Can Offer
- Market Access of Medical Devices Saudi Arabia
- Market Access of Medical Devices in Japan
- Why the ClinicalTrials Search Mask Could Cost You Hundreds of Thousands of Euros
- Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416
- Privacy Shield Agreement: What Its End Means
- How You Can Meet the Data Security and Protection Requirements for Digital Health Applications
- Regulatory Update or How to Stay Up to Date with Regulatory Requirements
- Digital Health Applications Ordinance (DiGAV, Digitale-Gesundheitsanwendungen-Verordnung): What Manufacturers Should Know
- Manufacturing and Marketing Personal Protective Equipment (PPE) in Compliance with the Legislation
- Why it’s not just the marketing department that should be interested in market research
- ISO 17664 - Processing of Medical Devices
- Validation of Machine Learning Libraries
- The MDR's Usability Requirements
- Transitional Periods MDR, regulatory requirements
- Clinical Investigation
- Health Care Facilities
- Generic device group versus device category
- Medical grade software
- CVSS
- 2. Amendment to IEC 60601-1 – What has A2:2019 changed compared to A1:2012?
- Market Access of Medical Devices in China
- MDR - Distributor Requirements
- IEC/TR 60601-4-5: The standard for IT security, is it also for stand-alone software?
- The FDA's Safer Technologies Program
- 3D Printing in Medicine: Avoiding Regulatory Traps
- Measuring Function
- ISO 10993 and Biocompatibility - Material Certificates Are Not Enough!
- Anonymization and Pseudonymization
- Class 1 Medical Devices according to MDR
- Multiple socket-outlets on medical devices
- Creating standard operating procedures for QM
- Third edition of ISO 14971
- Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report)
- Electronic signatures and electronic records: FDA and MDR requirements
- Purchasing controls: Supplier evaluation – supplier selection – supplier audits
- Heuristic Evaluation
- Document Control - Document Release
- Technical Documentation
- Risk Based Approach
- Vital physiological processes - decisive for classification
- Free Sales Certificates
- Parameterization of software
- Artificial Intelligence and Medical Devices
- Systems and Procedure Packs
- Laboratory Developed Tests LDT
- The FDA's Breakthrough Devices Program
- Declaration of Conformity
- Design input: What you shouldn’t forget
- Quality Policy and Quality Objectives
- Process Validation: Definition & Examples
- 21 CFR Part 11: Requirements You Should Know
- EU General Data Protection Regulation GDPR
- IT-Security in Healthcare
- MDSAP
- Differences ISO 13485:2012 and ISO 13485:2016
- Computerized System Validation CSV
- Audits & ISO 13485 Certifications
- Life Cycle Risk Management
- Conformity Assessment Procedure according to MDR
- MDR Rule 11: The Classification Nightmare
- Common Specifications
- Post-Market Surveillance
- EUDAMED: European Databank on Medical Devices
- Unique Device Identification UDI: What We Must Face
- Risk Analysis
- Mobile Medical Apps
- SOUP and OTS
- Safety Classes versus Level of Concern
- Software Testing
- Coding Guidelines
- Regulatory requirements for code reviews
- Software Architecture
- Software Requirements
- Agile Software Development
- Software Specifics
- Risk Mitigation
- Risk Acceptance
- Hazard and Hazardous Situation
- Harm and Severity
- Clinical Evaluation of Medical Products
- Verification versus Validation
- System Architecture
- Intended Use Description
- Update 14971:2012
- Usability Validation
- ISO 9241
- Main Operating Functions
- Medical Device Regulation MDR
- Unannounced Audit
- Design History File: What Your DHF should Include
- Medical Device Directive
- MEDDEV Documents
- Software as Medical Device
- Accessories for Medical Devices
- Classification of Medical Devices according to MDD
- CE Marking
- Notified bodies
- Essential Requirements - General Safety and Performance Requirements
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