Healthcare and medical device standards


ISO 13485:2016 is now available 
 

 

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Healthcare and medical device standards

The healthcare sector is highly regulated with standards, rules and legislation. To help manufacturers sift through the minefield of regulations, we can help with best practice guidelines, standards, supporting documentation and seminars.

We bring together industry and Government stakeholders to produce standards that maximise the safe and effective provision of healthcare throughout the UK. This is achieved by developing standards in support of legislation for medical device products, and providing guidance on the risk and quality management within the manufacturing process. Standards are also developed to describe best practice in healthcare service provision, and to support emerging industries such as eHealth, nanotechnology and regenerative medicine.

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ISO 13485:2016

The world's most popular standard for medical devices quality management


 

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Key Healthcare Standards

BS EN ISO 13485:2016 BS EN ISO 14155:2011 BS EN 62366-1:2015
BS EN ISO 13485:2016
BS EN ISO 14155:2011
BS EN 62366-1:2015
Medical devices. Quality management systems. Requirements for regulatory purposes Clinical investigation of medical devices for human subjects. Good clinical practice Medical devices. Application of usability engineering to medical devices
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Price:£238.00
Members save 50% : £119.00
view detailed information about this standard
Price:£238.00
Members save 50% : £119.00
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Publicly Available Specification (PAS)

PAS 2015:2010 PAS 5748:2014 PAS 150:2010
PAS 2015:2010
PAS 5748:2014
PAS 150:2010
Framework for health services resilience Specification for the planning, application, measurement and review of cleanliness services in hospitals Providing rehabilitation services. Code of practice
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