Quality Management Systems (QMS)
Transform your QMS from a barrier into a business asset
Are your quality management systems compliant?
Are there gaps in your processes that are holding you back from obtaining your QMS certification?
Are your processes creating avoidable delays when bringing your medical device to market?
Whether you need help complying with ISO9001 or ISO13485 or are looking to extend your projects scope, our QMS service is here to help.
We can help you:
Generate new QMS processes and documentation that complies with all the required regulations to get your site certified.
Update an existing quality management system to ISO13485, ISO9001 and country specific requirements (i.e., MDSAP Countries) to help you bring your medical device to market.
Improve your audit compliance by conducting gap analysis of your existing systems.
Carry out QMS simplification and consolidation to reduce the number of systems you have to give you confidence and clarity in the process.
Provide advice and support on eQMS introduction in your company.
Carry out system registration and ongoing system maintenance so that you can focus on other, more important aspects of the business.
Get in touch with us today at reach@colloccoconsultancy.com to arrange your free, no-obligation consultation session.
Systems that are running smoothly…
“Working with Jill at Collocco Consultancy was a pleasure. Amending the Quality Management System at Huntleigh Healthcare ltd to accommodate the Medical Device regulation 2017/745, delivering training and assisting with Technical files updates was never going to be an easy task and with Jill's help on this matter made the transition seem relatively easy”.
– Steve Monks, Director QRE Compliance, Huntleigh Healthcare Ltd.
Find out more about how we helped Steve and the team update their Quality Management System in order to comply with Medical Device Regulation 2017/745
Our Other Services
-
Medical Device and Technical Files
If you are looking to implement a Quality Management system or require scope extension we can help.
-
Training
Make sure your team has the skills needed to understand and comply with the most recent changes to regulations with one of our training courses.
Can we help with your Quality Management Systems (QMS)?
Why not book a call with us today, to see how we can help you improve your quality management systems, whether it’s for certification, compliance, reducing delays or anything else?