UKRP (UK Responsible Person)
A UKRP (United Kingdom Responsible Person) represents non-UK medical device manufacturers, ensuring compliance with UK regulations.
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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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Maria
2024/1860 Template confirmation letter
The document is a formal notification from a Notified Body (NB) confirming receipt and acceptance of a medical device manufacturer.
pharmaserviceinc
EU Updates Standards for Medical Devices 2024/815
The European Commission recently issued a decision updating standards for medical devices, aiming to ensure their safety and efficacy....
Maria
IMDRF 2024 Updates: Key Changes and New Procedures
IMDRF has released updates for 2024, focusing on enhancing regulatory convergence and ensuring the currency of its documentation in this doc
Soledad
EUDAMED 3.8.0: New Version Deployed with Enhanced Features
The European Database on Medical Devices (EUDAMED) has launched its latest version, 3.8.0.
Soledad
Remanufacturing of Medical Devices: New FDA Guidance for Industry and Service Providers
The FDA’s new guidance on Remanufacturing of Medical Devices with significant step towards ensuring clarity and consistency.
Maria
FDA US Agent Services with AF Pharma
AF Pharma's US Agent services provide invaluable support, ensuring compliance, smooth operations, and proper labeling for health products.
Maria
Medicines Submissions to the MHRA: A Comprehensive Guide
This blog provides a detailed walkthrough on how to make Medicines Submissions to the MHRA
pharmaserviceinc
Regulatory Landscape for In-House IVDs in Australia
In the dynamic world of medical diagnostics, Australian laboratories engaged in the manufacture of in-house in vitro diagnostic medical...
Maria
Legacy Devices (MDD CE marked devices)
Navigating the transition from MDD to MDR for Legacy Medical Devices, medical devices with CE marking under MDD. Check the information!
Maria
BioCat webinar
Explore health product trends, innovations, and success strategies in our webinar, "Opening Doors to Health Product Opportunities."
Maria
Medical device and IVD classifications
EU MDR and IVDR: Classifications & QMS are keys to compliance. Navigate changes for safer, effective medical devices in the EU
Soledad
Harmonizating the QSR CFR 820 with ISO 13485:2016
Navigating the Transition Taken from Brian Newbery, Founder of Fast-Track QMS Consultants As we enter a new era in the regulatory...
Maria
New MHRA Roadmap
MHRA's 2024 roadmap enhances UK medical device regulations, prioritizing patient safety, AI/ML guidelines, and international harmonization.
Maria
MDSAP NEWS!
MDSAP news. A new manual has been issued.
Maria
FDA US Agent Services with AF Pharma
FDA US Agent services
Soledad
Borderline Medical Devices: Ensuring Regulatory Clarity for Public Health and Market Integrity
EU's Manual on borderline medical devices clarifies classification rules, ensuring public health safety & market integrity
Maria
Application of ISO/IEC 17021-1 in ISO 13485
ISO 13485 certification demands strict adherence to ISO/IEC 17021-1:2015, ensuring QMS quality in medical devices.
Maria
MoCRA - FDA and Cosmetics regulation
FDA MoCRA brings new regulations for the US cosmetics registrations.
Maria
New UK Post-Market Surveillance (PMS) Rules for Medical Devices
UK PMS Regulation is essential for medical device manufacturers.
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