Class IIa/b/Non-General/Class B, Class C or Class D IVD Self Certification CE Marking
- 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 lifecyle, 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.
- Liaison with Notified Bodies.
- Competent Authority registration.
Additional activities (Client responsibility)
Regulatory Registration fees
Notified Body fees
Costs will need to be determined and quoted for on a bespoke basis, based on the Client’s specific requirements and deadlines for entering the market. However, for illustration, a typical Class IIa/b project (including the QMS build and ISO certifications) takes between 12- and 24-months end to end, primarily due to Notified Body waiting times and processes plus the need to establish a high yield of clinical efficacy, performance and safety data.
Clients are likely to need between 1 and 2 days consultancy support per week, to include regulatory, quality, safety and data protection subject matter expertise input.
A cost will be applied for each individual registered medical device.
Requires a QMS project and ISO 13485 certification to be in place or having an existing QMS and existing ISO 13485 certification.