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The importance of quality in medical device development is set to rise because:

  • As more complex and innovative devices are created and user environments evolve, with increasing emphasis for use of devices and therapies in the home, there is a high potential for the occurrence of significant quality issues.
  • When quality problems occur, their impact is likely to be greater as a result of increased regulatory, legal and media attention.
  • More therapeutic options are being made available, enabling direct comparisons between different products, highlighting differences in quality and safety between medical devices.

How we can help

Do you want clear, effective and useable processes and procedures that comply with Medical Device regulations and support shorter development projects?

Then let us handle your Quality System requirements.

Improving your Products & Services

Quality SystemsQuality Management Systems are about improving your products and services.

Your quality system should cover both internal work processes e.g. administration and management as well as to operational issues and external outsourced work processes, products and services. Intelligent quality management is how we help you get there.

All documents and procedures relating to your Quality Management System should have a few things in common, they should;

  • Make your intentions and working practices clear and applicable to the people that use them.
  • Be intelligent, easy to read and follow, with a logical flow.
  • Be a true reflection of how people operate.

We can provide you with bespoke guidance and support for areas such as;

  • Gap assessment of your Quality Program or review of your Quality Manual
  • Developing your new QMS or providing you with a Quality Plan
  • “Bolt-on” QMS elements to your existing system
  • Continuous Quality Improvement reviews and solutions
  • Training in your new Quality Procedures
  • Training on specific regulatory topics, such as computerised systems, 21 CFR 11 compliance, Human Factors requirements

We can either supply resources to help implement your systems and procedures or we can research and write it all for you, train your staff and hand it over to your internal resources to maintain.

Quality Benefits

We integrate quality and regulatory requirements into your business, product design and verification & validation processes, ensuring that your development achieves compliance as a matter of course. The typical benefits our clients gain are;

  • Effective management of risk through risk mitigation strategies
  • Reduction in development process costs
  • Shortening the time to finish development
  • Confidence in supplier capabilities and supplier quality
  • Validated product designs and processes

 

Get in touch today

Either contact us directly using the form below, or alternatively at *protected email* or +44 (0)1270 61 86 93

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