Class I Medical Device, General IVD or Class A IVD Self Certification CE Marking

Project Scope

• Support to the Client to implement the QMS into the product/software development lifecycle as defined so that the appropriate evidence can be generated in a series of technical documents and the business as usual process is in place.
• Full CE/UKCA project planning, identification of key project milestones, deliverables, deadlines, and responsible owners.
• Set up of a project specific instant messaging channel for immediate and quick replies to questions.
• Project kick off meeting where the entire project is presented end to end.  Meetings arranged for specific deliverables that require additional support to understand and achieve the requirements, eg. labelling, IEC 62304 software development life cycle, clinical evaluation, etc.
• Guidance and mentorship to structure the software/product development lifecycle to meet the required standards.
• Guidance to the Client on how to complete the required technical documents, including initial explanation, links to the appropriate MEDDEV guidance and QMS standard operating procedures, templates and work instructions and continual document review until the legislative acceptance criteria are met.
• Full implementation of risk management harmonised into the software/product development lifecycle.
• Compliance assessment according to the required medical device legislation.
• Competent Authority registration.

Additional activities (Client responsibility)

Regulatory Registration Fees