Regulatory Affairs and Quality Systems Compliance Consultancy
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Maetrics works with companies in the medical device sector to ensure they operate within the relevant regulatory framework, and that they comply with the quality systems demanded by their products. It provides regulatory and quality systems services worldwide, including in Europe, the US, Canada, Australia, New Zealand and Japan.
Regulatory and quality systems for the medical device industry
Maetrics helps you turn the challenge of regulatory and quality compliance into business improvements. Our expertise in medical device directives and standards means that we take a solution-based approach that is tailored to your needs and is fully compliant. Backed by over 80 years of combined experience across sterile and non sterile devices, you can be confident that we will break the regulatory bottleneck, on time and on budget.
Medical compliance systems for 510(k) and CE approval
Maetrics can assist with:
- CE marking, 510(k), CMDCAS and other worldwide regulatory compliance
- Specific projects such as technical file authoring, sterilisation validation and internal auditing
- Covering skills gaps
- Filling knowledge gaps
- Supporting growth into new markets
- Supporting growth with new product lines
- Specialist fields (microbiology, sterilisation, risk management, clinical evaluations and biological reviews)
- Interim Cover (maternity, sickness, urgent need)
- Resolution of auditor findings,
- Global coverage - including the US, Canada, Australia, Europe and others
- Medical devices training
- Candidate screening for regulatory and quality positions
Specialist knowledge and support for regulatory compliance
There are six key service areas that Maetrics focuses on, each providing the right balance of on-going practical support and specialist knowledge. The first is regulatory compliance; Maetricscan take the regulatory pressure off you, so that you are able to focus on preparing your product for market.
Practical quality assurance solutions
All Maetrics consultants are lead auditors who have a wealth of experience across the medical device industry. Whatever your requirements, Maetrics has a practical solution for you and can boast a 100% success rate in quality assurance.
Contamination control and microbiology
Your product and reputation will stand or fall depending on patient safety, making contamination control and microbiology a number one priority for any medical device manufacturer. The highly experienced and qualified microbiology consultants at Maetrics can efficiently identify the root causes for concern and tackle them effectively.
Specialist sterilisation knowledge
Maetrics offers in-depth sterilisation knowledge to its client base. On its staff, this consultancy can boast to have the only microbiologist in the country to have worked with the largest contract sterilisation companies. Its expertise spans from EtO, irradiation, steam, dry heat and more.
Quality management system auditing
Auditing is vital to compliance and maintaining a quality system, but time and resource constraints can often mean that it is not at the top of the priority list. Maetrics will take the hassle of auditing off your hands. All of our consultants are lead auditors and you can trust us to identify non-conformances and practically resolve issues.
EU authorised representative (EUAR) for manufacturers
For manufacturers based outside of the EU, appointing an authorised European representative is an essential step to market in the region. Maetrics's provision of EUAR service is a gateway to the European market.
Quality, compliance, sterilisation and cGMP training courses
Maetrics also offers the following training courses:
- CE Marking - introduction to the medical devices directive
- Compilation of a technical file / design dossier
- Risk management -ISO 14971
- Risk management - Usability Engineering & Electrical Medical Equipment
- Biological evaluation of medical devices - ISO 10993-1
- ISO 13485 internal auditor
- FDA quality system inspection technique
- Sterilisation - ethylene oxide
- Sterilisation - gamma and electron beam
- Clinical Evaluations - how to comply with MEDDEV 2.7/1
- Clinical trials for medical devices
- Post market surveillance and vigilance
- Apps and software as medical devices
- Process validation - regulatory requirement for IQ, OQ, PQ
- The medical device directive recast
- Cleanroom good manufacturing practice (cGMP)
For more information, please visit our website or contact us using the form below.