Congratulations to Laura Taylor in achieving her qualification as a lead auditor for ISO 13485 (Medical Device Quality Management Systems).

Laura Taylor, Manager, Regulatory Affairs Medical Technology has successfully completed the ISO 13485 accreditation as a lead auditor for ISO 13485 (Medical Device Quality Management Systems). Her achievement will allow tranScrip to further expand their medical device support offering to clients, to include ISO 13485 QMS support, auditing of client QMS systems and the quality systems of their suppliers”

In addition to tranScrips current Regulatory offering, tranScrip can now provide EN ISO 13485 Quality Management Systems support including but not limited to
– Supplier QMS Audits
– Internal QMS Audits
– Preparation for Health Authority and Notified Body Audits of QMS
– General Review of QMS Compliance (SOPs, WI, Templates, Forms, Policies)
– Support for QMS implementation

tranScrip would like to congratulate Laura for this achievement and we look forward to passing these benefits onto our clients.

Do you have a medical devices requirement? Get in touch with a member of our team.

If you missed our Medical Device UKCA Article, catch up now.