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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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Digital Health in Germany
Germany’s digital health sector is booming, but navigating market access, regulatory compliance, and reimbursement pathways is challenging.
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Digital Medical Devices
The EU regulatory landscape for Digital Medical Devices (DMDs) is evolving, incorporating the MDR, IVDR, AI Act, and HTA Regulation.
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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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