We offer consultancy related to CE certification and can provide ISO 13485 compliant Quality Management Systems & product Technical Files for small to medium sized medical device companies.
We can support you to build a transparent, fully integrated and compliant systems that help support all aspects of business function, especially those necessary for CE Marking and launching new products.
We are pleased to offer the following services:
A quality management system (QMS), compliant to ISO 13485:2016, containing more than 50 procedures and associated templates. By understanding the clients need, we create, install and train a QMS that works in harmony with their business and fulfils all the requirements of ISO 13485:2016.
A Technical File containing a wide range of completed documents that must be numbered, structured and traceable. For companies developing Software classified as medical devices, gaining Regulatory Approval can be a slow and confusing process. That is why we have developed a Technical File that can be used by many clients as well. Using our temple for a technical file can save you hundreds of hours of administrative work and will help you structure your entire work. By using our system, you can ensure you meet all the requirements necessary for Regulatory Approval.