We provide independent and valuable auditing expertise to ensure that your products continue to  meet all the requirements of the appropriate standards,.  We identify managements gaps and make recommendations for improvement of your management system. Our consultants are IRCA registered and perform audits on behalf of notified bodies, certification institutions, and stakeholders. We understand the complexity of human behavior and culture in processes and we also know how to identify business risks can recommend risk mitigation solutions.

Our auditors are IRCA registered and or do have significant experience in the following areas:

  • auditing management systems against international standards such as ISO 9001, ISO13485;
  • auditing product technical files;
  • assessment of clinical evaluations;
  • outsourced processes and supply chain 
  • etc.   

Our focus is to identify existing and potential risks in your management system and your products, and we provide solutions that protect you from potential negligence and product liability claims. 

Internal Auditing

We offer a cost-effective and extremely professional internal audit service which adds real value to your organization. We do not aim to become a permanent fixture within your organization, as that can lead to complacency; we prefer to provide independent and valuable internal auditing expertise to ensure that you continue meet the requirements of the appropriate standards, and most importantly that the management systems really do benefit your organization. We do this by providing internal auditors who understand how a business works and how the management systems can support your business objectives.

 Integrated Management Systems Auditing

With many organizations being registered to more than one international standard the internal auditing workload can be daunting. By conducting integrated management systems internal audits this workload can be reduced. However, the skills required by your internal auditors will have to be increased in order to conduct effective integrated systems audits to two or more standards, and therefore training is essential. MRM provides integrated management systems auditor training and we can also supply experienced professional auditors to conduct integrated audits.

Product and or Professional Liability Risk Assessment 

Our risk assessment audits ensures that the underwriter will have valuable data in the pre acquisition underwriting processes. Based on our scan and risk report the broker and insurance company is able to refine the terms and conditions for this specific client. This will have a positive effect on the P/L ratio.

Pre-Assessment Audits

Whether you are seeking ISO9001 or ISO13485 registration for the first time you will want to avoid the embarrassment and cost of failure. Our pre-assessment audit will ensure that you will be able to address any issues which may prevent registration.

Supplier Audits

Suppliers can make or break your business; it is as simple as that. By conducting supplier and or distributor audits, your reputation will no longer be at the mercy of your suppliers.  Once a satisfactory supplier or distributor has been found, monitoring their performance and keeping track of any ongoing business developments is important.  Therefore, planned, periodic audits together with the ability to respond quickly to any specific changes in either your own or your supplier's circumstances is essential. Two main objectives of supplier audits are:

  • to ensure the correct processes are in place to provide consistent quality of supply;
  • to ensure they have adequate plans in place to avoid interruption of supply

MRM can assess (potential) suppliers and audit existing suppliers' performance to ensure that they contribute to the effectiveness of your organization’s success. Whether the objective is merely to assess that the supplier can/does meet contractual commitments, or if the supplier is capable of implementing the improvements you need, then MRM supplier auditors can provide a valuable and professional independent supplier audit service.

 MRM will provide you with the professional expertise and experience you need to manage this vital aspect of your business. Our Audit deliverables are:

  • Conduct (supplier) audits on your behalf in an audit plan
  • Provide a comprehensive  audit report on findings, including
    • Discussion of findings
    • Recommendations for improvement and achieving compliance
    • Support in addressing any issues raised by the audit including the formulation of an action plan of remedial actions and Corrective and Preventive Actions (CAPA)
  • Provide your staff with the relevant training required allowing you to conduct your own audits
  • Provide a service tailored to your specific needs

We view this process as an opportunity for our clients to develop and build mutually beneficial relationships with their suppliers.  This results in supplier audits becoming a positive and constructive exercise by both parties.

Our team consists of professionally qualified experienced assessors with the ability to deliver audits to the highest standards.  We use international auditing standards in all our assessments, ensuring that best practice is always applied.


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      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…