Advices and Remediation

Efficient, experienced, compliant and business focused solutions and advices in:

  • Regulations & standards:
  • Registrations e.g. in EUDAMED, FDA, MHRA;
  • Technical Documentation;
  • Design, development / change;
  • Materials selection / Testing:
  • Supply chain, manufacture, labelling, packaging, sterilisation, distribution;
  • PMS and PMCF.

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.

Advice Examples

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.

  • EU Notified body availability, NCR’s and withdrawal of EC Certifications.

  • Combination Devices.

  • Risk management.

  • 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.

  • Non-conformance control.

  • Post Market Issues, returms, complaints, Root cause analysis, CAPA.

  • Incident Reporting.

  • Issues arising from external QMS Audit or Technical Documentation Review.

We have also received questions such as:

  • Do we need to CE Mark + UKCA Mark?

  • Do I need to change my CE Mark documentation for UKCA Mark?

  • What is the UKNI Mark, will UKCA suffice?

  • 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?

  • We comply with the directives / regulation, why do we need to address new MDCG Guidance or MEDDEV’s?

  • Do I need a CE Mark for UK Devices only?

  • 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)?

  • I Have a Notified Body is this OK for UK?

  • 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?

  • Can I register my devices in UK without a UKRP?

Successes

To date we have successfully delivered and completed in-house advices, conducted remediation services in restoring registration, certificates and licences to clients in EU + UK, USA and Mexico.

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