Quality Assurance
The Medical Device and IVD Regulations have introduced new and more complex regulatory requirements that can impact your Quality and Information Security Management System (QISMS).
ReguLogix Consulting takes a pragmatic approach to implementing and maintaining Quality and Information Security Management Systems in accordance with ISO 13485, EU MDR/IVDR, FDA QMSR (21 CFR part 820), MDSAP, and ISO 27001. This ensures that your QISMS is effective, compliant, and ready for internal and regulatory audits.
ReguLogix Consulting offers comprehensive services to support your Quality and Information Security Management System needs, including:
ReguLogix Consulting takes a pragmatic approach to implementing and maintaining Quality and Information Security Management Systems in accordance with ISO 13485, EU MDR/IVDR, FDA QMSR (21 CFR part 820), MDSAP, and ISO 27001. This ensures that your QISMS is effective, compliant, and ready for internal and regulatory audits.
ReguLogix Consulting offers comprehensive services to support your Quality and Information Security Management System needs, including:
- Identifying appropriate QISMS standards
- Developing, implementing, and operating your QISMS
- Enhancing your existing Quality Management System
- Providing Document Control and related QISMS activities
- Conducting audits and assisting with Corrective Action Planning and Implementation
- Training and developing your team on QISMS requirements
- Performing supplier assessments
- Assisting with complaints and non-conforming product issues
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 cover various areas, including:
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 cover various areas, including:
- Internal audits
- Supplier audits
- Audit preparation and support for:
- Notified Body audits (CE certification or ISO 13485)
- US FDA Inspections
- Medical Device Single Audit Program (MDSAP)
- Resolving audit non-conformities and implementing Corrective and Preventive Actions (CAPA)
As part of your Quality Management System requirements, you may need to establish quality agreements with your suppliers.
We have the expertise to assist with drafting quality agreements and ensuring all necessary elements are included to comply with current regulations.
We have the expertise to assist with drafting quality agreements and ensuring all necessary elements are included to comply with current regulations.
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