Maetrics Regulatory Affairs and Quality Systems Compliance Consultancy

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.

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Press Release

Maetrics Completes Acquisition of High-Edge Consulting

High Edge Consulting has announced the completion of its sale to US-based company, Maetrics LLC.

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Maetrics

Head Office, BioCity Nottingham

Pennyfoot Street

NG1 1GF

Nottingham

United Kingdom

+44 115 921 6200 www.maetrics.co.uk Regulatory and Quality Compliance Consulting

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Press Release

16 October 2013

High Edge Consulting has announced the completion of its sale to US-based company, Maetrics LLC.

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22 April 2013

High Edge Consulting, leading regulatory specialist to the medical device industry, will be at MEDTEC UK this year to support new and established medtech companies with compliance solutions that meet their practical operational and budgetary needs.

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4 March 2013

Regulatory specialist and training expert to the medical device industry, High Edge Consulting, has launched six new training courses for 2013.

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20 July 2010

High Edge Consulting and Isotron, providers of contract sterilisation services, are pleased to announce their collaboration in the delivery of QA and RA support to the medical device sector. Isotron is Europe's leading provider of contract sterilisation services. Through a network of 19

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Regional Offices

Maetrics

Head Office, BioCity Nottingham

Pennyfoot Street

NG1 1GF

Nottingham

United Kingdom

+44 115 921 6200 www.maetrics.co.uk Regulatory and Quality Compliance Consulting

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