For obvious reasons medical devices and healthcare equipment demands the highest quality of manufacture and rigorous standards compliance. Conformance engineers have experience of working with global healthcare and pharmaceutical companies to advise them on the special requirements for CE Marking medical equipment.
- Outline the route to compliance for Manufacturers and Virtual Manufacturers.
- Support the process of achieving compliance to CE marking for manufacturers already complying with other international accreditation schemes
- General advice for all the Medical Devices legal roles, including distributors and importers.
- Classification of Medical Devices. Identify requirements from directives other than the Medical Devices Directive and from private compliance schemes: Machinery Directive, Bluetooth, PED, PPE, RoHS2, EMC, etc.
- Selecting the most appropriate harmonised and non-harmonised technical standards and the clauses that are applicable to your device, creating personalised compliance checklists.
- Prepare test plans for general investigation during the design and for final approval.
- Assistance with qualification and classification of stand-alone software.
- Assess the completeness and quality of your technical documentation (including instructions for the final user) and supporting you in filling the gaps.
- Leading your risk assessment sessions and conclusions
- Outline and integrate risk prevention measures, Post Market Surveillance activities and quality management system procedures
- Interact with the European authorities (e.g.: the MHRA in the UK, the HPRA in Ireland), submitting queries on your behalf and participating in active dialogues.
- Advice during the selection of suitable Authorised Representative.
- Recommend suitable Notified Bodies according to their presence on the market, their international mutual recognition agreements, availability, etc.
- Introduce you to our specialised network: testing laboratories, software engineers, clinical evaluators, funding experts, 3D printing etc.
- Guidance in establishing a supply agreement between the OEM and the Virtual Manufacturer
- Doing business in Asia: we are present in Asia and we offer inspection and auditing solutions to support you in monitoring your critical suppliers (http://www.conformance.co.uk/asia/
Our recent industry experience includes:
- Walking aids
- Diagnostic imaging
Frequently Asked Questions
I want to appear on the packaging of a medical device, but I did not take part in the development and design of the product, and the manufacturing and packaging activities are performed by a third party. What options do I have?
In this case, you can be a Virtual Manufacturer (also called Own Brand Label), an importer or a distributor. In all cases, you have responsibilities under the Medical Devices Directive. The diagram at this link can help you to identify what your role is:
You can find the answers to many more CE marking questions in our knowledgebase.
Other relevant products and services we offer
We offer templates and guidance packages, such as the Virtual Manufacturer package (checklists of compliance to the Essential Requirements of the Medical Devices Directive and technical standards, drafts of Declaration of conformity, pictograms for devices and information for the final user, etc.)
Concise reports answering your focused questions, reviewing declarations of conformity, etc.
Personalised training on the Medical Devices Directive and future Medical Devices Regulations can be delivered at your site or at Conformance. Topics span from a general introduction to the MDD to the technical standards that are applicable to your products and to any particular individual requirements.
Working together with your team, integrating activities such as review your technical documentation with training, so that your can learn what the MDD means for your product. Our recent experience with CE marking medical devices includes: Assembly of electronic COTS with software for medical devices Electronic cigarettes Walking aids Electro-cardiograms Devices for diagnostic imaging.