Advices and Remediation
Supporting you with efficient, experienced, compliant and business focused solutions and advices in regulations, standards, MEDDEV’s in relation to your devices, be that in technical documentation, design, development / change, materials, supply chain, manufacture, labelling, packaging, sterilisation, distribution and post-sale activities.
Sharing our knowledge of Quality Assurance (QA), Management Systems and Regulatory Affairs (RA) enabling efficient processes and remediation services. Such advices can arise from stand-alone enquiries, provision of an updating service, or may form party of our Consultancy or In-House Expertise and Remediation services.
Medical Device Sector Expertise
We commit to ensure clear and defined, dedicated objectives and support to:
Ensure a complete understanding of your enquiry / requirement(s).
Allocate appropriate, qualified and experienced resources.
Diligently communicate our Advices / Responses and assist with their implementation.
Our advices are diverse, international and range from answering questions and addressing issues such as:
National & International Medical Device Regulations.
Quality System Regulations / Standards.
Harmonised / National Standards.
Device classification and compliance routing.
Stand Alone Software and Classification.
Procedure / System Packs.
Notified body availability, NCR’s and withdrawal of EC Certifications.
Clinical Evaluation and clinical data requirements.
Device design and development.
Process validations: clean room, packaging, sterilisation, stability / shelf life, environment, transport.
Verification testing to ISO, ASTM, AAMI, EN and UK standards
Operational / Process / Issues / Changes.
Post Market Issues, returms, complaints, Root cause analysis, CAPA.
Issues arising from external QMS Audit or Technical Documentation Review.
We have also received questions such as:
All I need to do is self-declare to CE mark?
Do I really need to comply with…? or Can I get away with…?
Does this apply to our small company?
Do I need to conduct a risk assessment, it’s a simple, standard device?
Do I need to comply with the directive, our products are manufactured by a contractor?
Why do we need a quality system?
Why do we need to test for biocompatibility, the polymer is FDA approved?
Why undertake shelf life tests, the pouch supplier states 5 years?
I do not need to address the new MEDDEV I can do it differently?
How long does it take to gain approval?
What Notified Body should we use?
Can I get approval in country x because I have a 510k (or CE Mark)?
What is the requirements for country x?
I am changing the labels do I need to advise the Notified body?
Do I need an IFU?
I believe my product is a cosmetic product can you confirm it?
We don’t manufacture our devices, they are imported from China who are FDA listed, can I sell them here?
We manufacture the device for our client who has the 510k, do we need to comply with CFR820?
To date we have successfully delivered and completed in-house advices, conducted remediation services in restoring registration, certificates and licences to clients in Europe and UK.