Guides and Advice

IVD regulatory consultancy offered by Patient Guard in relation to the IVDR 2017/745

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Blog, EU Regulations, Guides and Advice /

In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.

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medical device consultancy

Medical Device Start-up

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations /

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

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A guide to ISO 13485

The Pragmatic Guide to ISO 13485 Quality Management Systems

Blog, Guides and Advice, Standards /

Establishing an ISO 13485 compliant Quality Management System is the definitive gateway to the global medical device and IVD market. As a professional regulatory consultancy, Patient Guard operates under our own ISO 13485 QMS, fully certified by BSI. We understand the exact realities, challenges, and milestones of the certification process because we live it ourselves, helping us deliver practical, audit-ready frameworks that support sustainable growth.

The Pragmatic Guide to ISO 13485 Quality Management Systems Read More »

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