Medical Device Blog

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

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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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A Guide to Finding GMDN Codes for Free - UKRP

If you work in the medical device industry, you may be familiar with the Global Medical Device Nomenclature (GMDN) system. GMDN codes are...

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Simplify Your Medical Device EU Technical File with AF Pharma Consulting

Are you a medical device manufacturer looking to enter the European Union (EU) market? Navigating the complex regulatory landscape can be...

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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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💊💊 BREAKING PHARMA NEWS- MHRA Medicines and future Medical devices updates! 💉💉

MHRA has just announced new regulatory recognition routes for MEDICINES.

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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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EU Representative - Clinical Trials

According to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, appoint a representative is required

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Affixing a CE Mark in your devices for EU

Some products require CE marking before they can be sold in Europe, like medical devices and machinery products.

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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...

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New FDA Guidance on Risk Management!

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational...

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Examples of Class III medical devices

Medical Device classification under MDR. Examples of MDR class III medical devices

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Best Practice Guidance for the Submission of EU Technical File and Documentation of Medical Devices

New guidance on EU Technical Documentation for medical devices

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Examples of Class IIb medical devices

Medical device classification examples. Class IIb under MDR rules.

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Examples of Class IIa medical devices

Medical device Class IIa examples

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Examples of EU Medical Device - Class I

Examples of medical devices classes

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Impact of extension of the MDR

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the...

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Foods for special medical purposes/medical foods: A global regulatory synopsis

Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.