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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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GPSR Registration
GPSR ensures EU product safety with stricter risk, traceability, and surveillance rules. AF Pharma offers expert support!
Soledad
GPSR Services
A Canadian electronics company expanded into the EU market with AF Pharma's GPSR services, boosting Amazon sales by 40% within six months.
Maria
GPSR Responsible Person
AF Pharma’s EU Responsible Person services ensure compliance with GPSR, helping businesses navigate EU regulations and maintain market.
Maria
AF Pharma’s UKRP Services for Norway
AF Pharma’s UKRP services helped a Norwegian medical device company enter the UK market swiftly, boosting UK sales by 35%
Maria
GPSR
AF Pharma offers EU Responsible Person services to ensure compliance with the GPSR, helping businesses navigate EU regulations.
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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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EUDAMED Nov 24
EUDAMED's phased roll-out under EU MDR/IVDR enhances device transparency, safety, and compliance. Prepare now for mandatory module use!
Soledad
UKRP Services Helped a US Company
AF Pharma’s UKRP services helped a US medical device company achieve rapid UK market entry, boosting sales and ensuring full MHRA compliance
Maria
MOCRA: FDA's New Cosmetic Regulation
MOCRA updates U.S. cosmetic laws, requiring FDA registration, GMP compliance, adverse event reporting, and safety substantiation for product
Maria
UKRP Services for Medical Devices
AF Pharma’s UKRP services for medical devices simplify UK compliance, enabling fast, reliable market access and growth in the UK.
Soledad
TGA to Accept FDA 510(k)
Devices supported by 510(k) clearances (unlike those with PMA approvals) must undergo a mandatory TGA application audit
Soledad
Cybersecurity in Medical Devices
Regulatory for Software as medical device (SaMD)
Maria
The PRRC
the introduction of the Person Responsible for Regulatory Compliance (PRRC) is one of the most significant changes for the MDR
Maria
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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MDR revision
Medical Devices Regulation - MDR Revision: European Parliament Takes Action. Medical Devices Regulation (MDR) (2024/2849(RSP))
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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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PMS UK Requirements
Post-market Surveillance (PMS) Statutory Instrument: The Future of Medical Device Regulations in Great Britain.
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EU Authorized Representative for Medical Devices
If you are a non-EU manufacturer looking to sell medical devices in the EU, you shall appointing an EU Authorized Representative
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How to Write a CER as per MDR
Writing a Clinical Evaluation Report (CER) that complies with MDR 2017/745 is a complex but critical task for medical device manufacturers.
Soledad
Electronic IFU
IFU electronic
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