Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

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Electronic IFU

IFU electronic

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Compliance GPRS Amazon

Selling products on Amazon within the EU and UK markets requires adherence to regulatory standards GPRS Amazon

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GPSR 2023 988

The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect

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New AI Act Regulation

Europe's AI Act enforces transparency, safety, and accountability in AI, ensuring responsible use and protecting consumers from risks.

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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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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.

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EU Updates for Medical Devices Standards 2024/815

The European Commission recently issued a decision updating standards for Medical Devices Standards 2024/815, aiming to ensure their...

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

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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.

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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.

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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.

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Medicines Submissions to the MHRA: A Comprehensive Guide

This blog provides a detailed walkthrough on how to make Medicines Submissions to the MHRA

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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...

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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!

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BioCat webinar

Explore health product trends, innovations, and success strategies in our webinar, "Opening Doors to Health Product Opportunities."

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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

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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...

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New MHRA Roadmap

MHRA's 2024 roadmap enhances UK medical device regulations, prioritizing patient safety, AI/ML guidelines, and international harmonization.

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MDSAP NEWS!

MDSAP news. A new manual has been issued.

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FDA US Agent Services with AF Pharma

FDA US Agent services