Medical Device Case Studies

ISO 9001 & ISO 13485 Management System Case Study

Culzean Medical Devices Ltd is an innovative and experienced medical fabric specialist dedicated to providing contract development and manufacturing of customised solutions to the medical device industry, both in Europe and the USA.

QCSL was involved in the training of management and staff in both ISO9001 and ISO13485 and from a very early stage has worked with the company to develop and implement management systems, performed the role of internal assessment and helped the organisation maintain certification to both international standards

The Medical Devices Industry is very dynamic and subject to many examples of new devices coming into the market. Change has been at the heart of Culzean Medical that has seen the company develop new partnerships, implement high quality and environmental processes to meet ever expanding client demands. QCSL has shared in that change and continues to provide independent advice and specialised assistance in assuring the company meets the requirements of the standard and national regulatory bodies.

Challenge

  • Develop and Implement an Integrated Management System
  • Maintain ISO13485 & ISO9001 Certification
  • Maintain and or reduce costs
  • Reduce likelihood of Client Assessment Visits
Russell Mobray Quality Director—Culzean Medical Devices Ltdwww.culzemed.com
QCS were initially approached as part of the company’s ongoing drive to maintain ISO certification over 7 years ago. At that time we were just looking for some training so we could get a clearer picture of what we needed to do in order to continue to comply with ISO9001/13485. I and other members of the management team were impressed by the QCS Tutor’s knowledge and presentation of the requirements that we decided to get some help both with the development of management systems and how we could simply but effectively monitor our processes. Being a small organisation, resource and costs have always been a premium to us, so as we were implementing a management system to comply with both ISO9001 and ISO13485, we started using the QCS consultant also as our internal auditor. An arrangement that is still in place today and that continues to give us real value in resource costs, keeps us up to date on issues within the market place and assures our ongoing compliance with the standards.

Results

  • Ongoing Successful ISO 13485 & ISO 9001 Certification
  • Simplify all documentation
  • Achieved FDA Approval (USA)

Benefits and Implementation

Through implementation of an integrated ISO13485 and ISO9001 Management System, Culzean Medical has been able to simplify its documentation process and manage their internal requirements relating to its clients and compliance with national and international regulations more effectively.

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