Advices2018-03-15T08:57:07+00:00

Advices

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.

Advice Examples

Our advices are diverse, international and range from answering questions regarding:

  • National & International Medical Device Regulations.

  • Quality System Regulations / Standards.

  • Harmonised / National Standards.

  • Device Classification.

  • Stand Alone Software and Classification.

  • Procedure / System Packs.

  • Compliance Routings.

  • Combination Devices.

  • Risk Analysis.

  • Clinical Evaluation.

  • Device Design.

  • Process Validations.

  • Testing

  • Operational / Process / Issues / Changes.

  • Non-conforming Product.

  • Post Market Issues / Complaints.

  • Incident Reporting.

  • 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?

Successes

To date we have successfully delivered and completed in-house advices, resource services to clients in Europe and UK for various term contracts.

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