Herman Rempe
Filtering
Published on:25 November 2025
Update
Annemieke’s key role as ‘Person Responsible for Regulatory Compliance’ (PRRC)
Uncategorized
Published on:24 November 2025
Update
Updated Regulation on Electronic Instructions for Use: What Medical Device Manufacturers Need to Know
Uncategorized
Published on:4 November 2025
Update
How Outsourcing ISO 13485 Internal Audits Strengthens Compliance for 2026
Uncategorized
Published on:27 October 2025
Update
Why Now Is the Best Time to Plan Your ISO 13485 Internal Audit
Uncategorized
Published on:15 October 2025
Update
Important IVDR timelines
Uncategorized
Published on:29 August 2025
Update
ATEX product directive conformity process
Uncategorized
Published on:4 September 2025
Update
The new EU Packaging Regulation: What medical device manufacturers need to know
Medical Devices
Published on:28 August 2025
Update
NIS2: What It Means and Who It Applies To
Uncategorized
Published on:27 August 2025
Update
Process Safety: A Must for Compliance with the Pressure Equipment Directive (PED) Assemblies
Uncategorized
Published on:31 July 2025
Update
The EU Toy Safety Regulation Is Coming: What Manufacturers Must Prepare For
Uncategorized
Published on:12 June 2025
Update
Become an expert in Quality Management with the Quality Manager (ISO 13485) training from Kader
General
Published on:16 May 2025
Update
Unlocking MedTech Innovation in Europe: A Call for Smarter, Faster Certification
Uncategorized