We have broad regulatory experience within the Medical Device Industry. We can support your team and project in the CE-marking process with Gap analysis and/or technical documentation. We can help you classify your product and identify applicable standards.
Example of our support:
… and other regulatory support
We have extensive experience in the quality field for Medical Device industry. We can support in writing specific processes or support you in implementing a full Quality Management System in compliance with ISO 13485:2016.
Other examples of support:
…. and other quality affairs support
We provide customized training within the regulatory and quality field in the Medical Device Industry.
Tell us about you needs and let’s discuss how we can support you.
We support our customers in all types of questions independent of the size of the assignment.
From solving one specific questions to long periods of support in regulations and quality issues that is currently happening in your day to day business.
We have long experience in MDD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 62366, IEC 62304, QSR (FDA 21 CFR Part 820, Part 11) and other regulations and standards in medical device industry.
Together with our partners, we can offer our customers professional support in a very broad area within Medical Device regulations.
As an experienced team, our aim is to support you as a customer in a timely and cost effective way.