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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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EUDAMED Nov 24
EUDAMED's phased roll-out under EU MDR/IVDR enhances device transparency, safety, and compliance. Prepare now for mandatory module use!
Maria
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
Soledad
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.
Maria
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)
Soledad
The PRRC
the introduction of the Person Responsible for Regulatory Compliance (PRRC)Â 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
Maria
MDR revision
Medical Devices Regulation - MDR Revision: European Parliament Takes Action. Medical Devices Regulation (MDR) (2024/2849(RSP))
Maria
Artificial Intelligence - AI in Medical Devices
As Artificial Intelligence - AI in Medical Devices continues to revolutionize industries across the globe
Maria
PMS UK Requirements
Post-market Surveillance (PMS) Statutory Instrument: The Future of Medical Device Regulations in Great Britain.
Maria
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
Maria
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.
Maria
Electronic IFU
IFU electronic
Soledad
Compliance GPRS Amazon
Selling products on Amazon within the EU and UK markets requires adherence to regulatory standards GPRS Amazon
Soledad
GPSR 2023 988
The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect
Soledad
New AI Act Regulation
Europe's AI Act enforces transparency, safety, and accountability in AI, ensuring responsible use and protecting consumers from risks.
Soledad
UKRP (UK Responsible Person)
A UKRP (United Kingdom Responsible Person) represents non-UK medical device manufacturers, ensuring compliance with UK regulations.
Maria
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.
Maria
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...
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