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.