G.P.B. provide practical, efficient, experienced, advices in all medical device regulations, standards, MEDDEV’s in relation to your devices, be that in design, development / change, materials, supply chain, manufacture, labelling, packaging, sterilisation, distribution and post-sale activities.
Our knowledge of Quality Assurance (QA), Management Systems and Regulatory Affairs (RA) enables the delivery of valuable advices to our clients. Such advices can be from stand-alone enquiries, provision of an updating service, or may form party of our Consultancy or In-House Expertise services.
Medical Device Sector Expertise
Your success is our aim by providing value added services founded on our commitment to clarity of objectives and defined, dedicated support to:
Ensure a complete understanding of your enquiry / requirement(s).
Research / allocate appropriate resources.
Diligently communicate our Advices / Responses.
Our advices are diverse, international and range from answering questions regarding:
National & International Medical Device Regulations.
Quality System Regulations / Standards.
Harmonised / National Standards.
Stand Alone Software and Classification.
Procedure / System Packs.
Operational / Process / Issues / Changes.
Post Market Issues / Complaints.
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, resource services to clients in Europe and UK for various term contracts.