News/Blogs - Advena Ltd

Advena Announced as Patron of The Commonwealth at 75

Who should I choose for ISO13485 certification – a Certification or Notified Body?

Navigating UDI – Highlights from Webinar hosted by GS1

Introducing Nirjit Nahal: Our New Quality Systems Specialist

What evidence do I need for my Class Ir device (under EU MDR 2017/745)?

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Are YOU ready for the next EU MDR deadline?

The new Regulation (EU) 2024/1860, amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). What do manufacturers need to do?

EN ISO 10993 – Biological Evaluation of Medical Devices – Q&A’s

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Outsourcing Person Responsible for Regulatory Compliance (PRRC) Article 15 EU MDR 2017/745 or IVDR 2017/746

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What Essential Clinical Evidence Is Needed for Legacy Devices?

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Mastering Clinical Evaluation Through Equivalence: What are the opportunities and pitfalls?

Top 5 audit non-conformities raised by BSI

A dedication to Alison Harris

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Are you ready for 26th May 2024 deadline?

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Do you have a Class I device that will be up-classified under MDR EU 2017/745?

The Legal Impacts of Non-Compliance – How to prevent a manageable issue from escalating into a crisis

eQMS Software – Getting it right first time

Regulatory Compliance

How Compliance Affects Your Business and Legal Defense

Bespoke Medical Device Training Services by Advena Consultancy

Simplify Medical Device Regulation with Advena Consultancy

Streamlining Device Regulatory Compliance for SMEs

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Hybrid Audits

MHRA yellow card

Unannounced Audits

The UK government review of units of measurements

New Reporting Rules for Medical Device Incidents to MHRA

Aerosol Dispensers

Does UK REACH apply to your cosmetic ingredients?

FDA relaxes UDI requirements for some Class I devices

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