Medical Device Quality Management

Meet regulatory requirements and customer expectations  

We specialise in supporting businesses achieve ISO 13485:2016 certification and compliance with medical device regulations implementing systems that meet your specific needs … from development of the system through to training and helping you through certification audits.

How PS Partnerships can help:

  • ISO 13485:2016
  • EU Medical Device Regulations
  • Medical Device Directive (UK MDR 2002)
  • ISO 14971:2019

ISO 13485:2016

ISO 13485 is the internationally recognised standard for quality systems in the medical device industry.  Implementing and achieving certification to ISO 13485:2016 demonstrates to both customers and regulators your quality commitment to medical devices and that your processes manage risk effectively in design, development and manufacture.

ISO 13485 places a significant focus on legal requirements, regulatory compliance, risk mitigation and assessment but complying with the standard helps you to improve your understanding of how these requirements impact your organisation and your customers.

EU Medical Device Regulations 

All medical devices placed on the EU market after 26 May 2021 will need to comply with the EU Medical Device Regulations (MDR) or In Vitro Diagnosis Regulations (IVDR).  Compliance with the Medical Device Directive will no longer be acceptable.

The new requirements ensure high standards of quality and safety for medical devices and PS Partnerships are here to support your MEDR compliance transition.

Medical Device Directive

The UK will continue with the Medical Device Directive 93/42/EEC 1993 which is given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002).  But on the horizon is the Medicine and Medical Devices Bill which builds on UK MDR 2002 to give added protection to patients and increase the scrutiny of medical devices that reach the UK.  It is thought that this will strengthen the UK MDR 2002 and bring it closer to EU MDR.

ISO 14971:2019

In the medical device industry, risk management is a vital aspect of the lifecycle of your product.  Risk management goes beyond product development and manufacturing.  It’s a systematic process centred around product hazards when using the medical device … from concept and design through to decommissioning and disposal.  An effective risk management process is an integral part of medical device design and manufacture.

ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire lifecycle of a device.

If you want to transform your current quality management system, implement a system from scratch or understand more about how to comply with the medical device regulations, get in touch at systems@ps-partnerships.com to find out the critical steps you need to take.