A Concise Action Plan
The Client
LaproSurge Ltd are a UK based medical equipment manufacturer specialising in single use laparoscopic surgery equipment. Their focus is to continually deliver the highest quality medical devices.
The Challenge
The constant updates in medical device regulations is a common challenge for providers of medical devices. When Laprosurge first approached Collocco, they were changing from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745. In order to remain compliant, LaproSurge’s Quality Management System and various technical files needed to be updated.
The Solution
Collocco helped Denise and the LaproSurge team by conducting a gap analysis for their Quality Management System and Technical Files against the Medical Device Regulation 2017/745. We also assisted with Notified Body Queries and the update of their Quality Management System and Technical Files to accommodate Medical Device Regulation 2017/745 requirements.
Here’s what they had to say…
“Jillian made a very clear plan and budget. Jillian and her team were able to provide clear and concise action plans, explain the requirements and present solutions to close the gaps. To work within our agreed upon budget, I was very impressed. Over the years, I have dealt with many consultants, and I can attest that Jillian displayed a level of professionalism that is seldom matched. It has been a pleasure to have worked with Jillian….”
- Denise Lane, QA/RA Manager at LaproSurge Ltd. Source
