Pragmatic implementation and maintenance of Quality and Information Security Management Systems, audit preparation, and supplier quality management — aligned with ISO 13485, EU MDR/IVDR, FDA QMSR, and ISO 27001.
Pragmatic development, implementation, and ongoing operation of Quality and Information Security Management Systems compliant with ISO 13485, ISO 9001, GMP, ISO 22716, EU MDR/IVDR, FDA QMSR, and ISO 27001
Comprehensive audit preparation and support for internal audits, supplier audits, Notified Body CE certification audits, US FDA inspections, and Medical Device Single Audit Program (MDSAP)
Expert drafting of quality agreements with suppliers and partners, ensuring all necessary elements are included to comply with current regulations and strengthen your supply chain quality management.
Evolving regulations for Medical Devices, IVDs, Cosmetics, and Food Supplements introduce increasingly complex requirements that can impact your Quality and Information Security Management System (QISMS).
ReguLogix Consulting takes a pragmatic approach to implementing and maintaining QISMS in compliance with ISO 13485, ISO 9001, GMP, ISO 22716, EU MDR/IVDR, FDA QMSR (21 CFR Part 820), MDSAP, and ISO 27001. Our expertise ensures that your systems remain effective, compliant, and audit-ready — supporting seamless regulatory approval and market success.
Our comprehensive QISMS services include:
For most classes of medical devices, you will undergo regular announced and unannounced audits by the relevant Notified Body and/or Regulatory Agency to ensure ongoing compliance. Failing such audits may lead to the suspension or withdrawal of your certificate.
Additionally, conducting internal audits aligned with your Quality and Information Security Management System is essential to verifying and maintaining effective controls. ReguLogix Consulting can assist you in preparing for both internal and external audits, ensuring thorough readiness.
Our expertise and support covers:
As part of your Quality Management System requirements, you may need to establish quality agreements with your suppliers and critical service providers.
Quality agreements are formal documents that define the responsibilities, expectations, and quality standards between a manufacturer and its suppliers. They are a key element of supply chain management under ISO 13485, EU MDR/IVDR, and FDA regulations.
ReguLogix Consulting has the expertise to assist with drafting quality agreements and ensuring all necessary elements are included to comply with current regulations. Our services include:
This site is governed solely by applicable laws and governmental regulations for England and Wales.
Use of this site constitutes your consent to application of such laws and regulations and to ourPrivacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. Cookie Policy
Copyright © 2024 ReguLogix Consulting Limited. All Rights Reserved.
