Medical Device Blog

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

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EC Rep Now

AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.

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UKRP for Medical Devices

AF Pharma’s UKRP for medical devices helps EU companies navigate UK compliance, boosting market entry and growth for manufacturers across EU

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Artificial Intelligence - AI in Medical Devices

As Artificial Intelligence - AI in Medical Devices continues to revolutionize industries across the globe

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Electronic IFU

IFU electronic

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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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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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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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FDA US Agent Services with AF Pharma

FDA US Agent services

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US FDA Medical Device Establishment Registration

US FDA Medical Device Establishment Registration is the process where medical devices facilities are registered in the US FDA.

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Draft UK Post-market Surveillance Requirements

We have some exciting news to share regarding the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has recently...

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Medical Device Technical File Generation

AF Pharma offers experience and expertise to simplify the process of technical file generation, ensuring regulatory compliance.

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New Draft Compromise Amendments for AI in the EU

A new Draft Compromise Amendments for AI in the EU has been published and you can download it below. Also, AF Pharma can help you.

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Regulatory Landscape for Custom-Made Medical Devices in the EU

Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes

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MHRA Updated Guidance on Software: Understanding Medical Device Status and Regulation

In the ever-evolving field of medical devices, software applications (apps) are playing an increasingly significant role. To ensure the...

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Navigating the Canadian Regulation Framework for Medical Devices - AF Pharma's Expert

AF Pharma's team of regulatory experts can guide manufacturers through the entire process, from document preparation to submission.

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Do you want to have a CE mark? Follow the steps below

A CE mark logo is an essential identification for certain products in the EU, including medical devices and machinery.

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Regulating medical devices in the UK - April update

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. This is an extract...