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

  • More complex and innovative devices are being created, and user environments are evolving, with increasing emphasis for use of devices and therapies in the home; there is a high potential for the occurrence of significant quality issues.
  • With increasing regulatory, legal and (social) media attention, when quality problems occur, their impact is likely to be greater and readily visible to a wider audience.
  • More therapeutic options are being made available, enabling direct comparisons between different products, highlighting differences in quality and safety between medical devices.

If you want clear, effective and useable systems and procedures that comply with Medical Device regulations and support shorter development projects to meet the rising challenges , then let us help.  We can handle your Quality Management System (QMS) requirements and smooth your way to making your QMS work for you.

Improving your Products & Services

It is a fact that businesses benefit from having a good, useable QMS in place.  One of the biggest plus points from having a QMS is that it makes people think about their operations and actions.

6 major benefits we have found from companies having a useable QMS:

  • Procedures and guidance provide people with clear structure to follow, which helps a company to run more efficiently and effectively. They bring consistency to the workplace; operating in a consistent manner improves output and provides customers and clients with confidence.
  • A QMS exposes companies to fewer risks and improves financial performance, which adds up to higher profits.
  • Having procedures, structure and good documentation in place ensures that decisions are made based on rationality, logic and an understanding of past actions. Having the ability to make better decisions enables companies to continuously improve.
  • The relationship you have with your suppliers impacts on your overall success. A good QMS provides a platform to effectively evaluate your suppliers, manage supply risks, and can be used to better manage and develop relationships/partnerships through effective auditing of their services.
  • Control of documents and records provides easy to follow, clear guidance.  Employees can track the status of documents and be assured that they are following the correct instructions or procedures.  The business has assurance of traceability from the starting materials through the actions performed, to the finished product or service.
  • With procedures and processes established, having internal controls checks both their effectiveness and how well they are being utilised to help flag-up potential issues before they become an expensive problem.

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.

The benefits of an effective QMS

We integrate quality and regulatory requirements into your business, product design, manufacturing / assembly 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