Providing Medical Device Quality Assurance and Regulatory resource

Quality does not happen by chance and can only be achieved by a full understanding of customer expectations, sources of variation and risk

01

Fractional Quality Assurance and Regulatory resource 

If you are a start-up and not yet in need of a full-time QA and/or RA resource then we can provide resource from a few hours to a few days per week. We can set up your Quality Management System (QMS), compile technical documentation and conduct regulatory submissions.

We have experience in many global jurisdictions including EU (MDR/IVDR), FDA, TGA. HSA. We can also offer clinical reviews as required to ensure your device is, and remains clinically viable through the development process. Equally, if you have no idea what you may need, contact us and we will help you.
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02

Remediation or Audit Preparation work

If you have had a bad audit and have corrective actions within your QMS or submission documents to resubmit we can help. With expertise in Root Cause Analysis, risk management and corrective actions we can help address any issues that are found.

We are also able to provide an independent review of any current documentation or processes.
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03

Quality, Regulatory and Clinical Consulting

We provide strategic business consulting services to help organisations optimise their QA and/or RA operations.

We offer

- Ad-hoc or ongoing advice

- Document preparations such as;

  • Risk assessments/reports
  • AI roadmap and documentation
  • AI ISO24001 quality system implementation
  • Clinical assessments/reports
  • Literature research
  • PMS
  • Problem solving
  • Independent auditing
  • Training (Risk, ISO13485, GMP)​


​If your organisation is in need of a clinical resource we can also assist.
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04

Country Representation and Sponsorship

We are able to offer a range of Country Representation and Sponsorship services

We are able to offer the following services:​

  • Manufacturer PRRC service to micro and small manufacturers
  • EU Authorised Representation though presence in Malta
  • UK Responsible Person
  • New Zealand Sponsorship with presence in Hamilton (NZ)
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05

Independent Auditing and Technical Reviews

In most start-ups everyone is involved with everything - as it should be. Many SME's struggle to find someone who is truly independent to audit specific areas as is required by QMS regulations.

We can help plan, conduct some or all of your internal and/or supplier audits. Being independent we will see things as a regulator would likely see them. ​​In start-ups you can get too close to what you are doing and not see the wood for the trees so having an independent review of technical documentation is important.
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06

Independent Design Reviewer

Similar to auditing, having that Independent Design reviewer is not only a regulatory requirement but also makes sense.

Too often companies have an independent reviewer who is merely there to tick a box without realising this approach could come back to haunt them. Independent reviewers need to be exactly that, independent, and not be afraid to ask questions that may not be obvious as this is exactly what a regulator will do.
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