Regulatory and Quality Management System Compliance

Service overview

Real Regulatory offer a wide range of regulatory and QMS services and can provide a dedicated team with the required expertise to support your site’s regulatory and quality system compliance requirements.

Regulatory/QMS Compliance Consulting Services

  • Assisting clients with planning, developing and implementing a quality management system compliant with various applicable European Union (EU) standards (ISO 13485, ISO 9001), GxP and the Canadian Medical Devices Regulations (CMDR)
  • Conformity Assessment System (CMDCAS) requirements, where needed
  • Update of existing quality management system/regulatory processes to reflect current site activities
  • Providing guidance on all aspects of a quality management system including training, documentation and documentation control, change-control, (pharmaco)vigilance, GxP etc.
  • Gap Analysis reports highlighting gaps/areas of improvement in existing quality systems
  • Creation/updating of specific processes (for example risk management as per ISO 14971, vigilance/adverse event reporting for medical devices etc…) to meet regulatory and quality system requirements
  • Pre-inspection audits of regulatory and quality management systems to assist in preparation for an inspection and to assess readiness for certification/registration
  • Pre-inspection training (including mock-interviews to prepare staff for an audit environment and best conduct for inspections) and how to respond to inspection reports
  • Pre- and post-inspection liaison with Notified Body/regulatory authority inspectors
  • Support prior to, during and after Market Compliance Audits (post-inspection) by the Competent Authorities/Notified Body, in the following areas:
    • Compliance of promotional material and labelling with Marketing authorisations/Medical Device legislation
    • Product quality compliance
    • Implementation of new product information
    • Hospitality, Meetings, Sponsorship activities
    • Recalls, quality defects, complaints
    • Medical Information
  • Perform supplier audits on behalf of client companies
  • Conduct audits and generate reports highlighting gaps/areas of improvement in your regulatory compliance activities
  • Conduct due diligence technical reviews and consulting on a product file/dossier
  • EU Authorised Representative Services to non-EU manufacturers (medical devices and In-Vitro Diagnostics (IVDs))

Typical projects

Project: Set up of a new Regulatory Affairs department in Ireland.
Client: A large pharmaceutical company
Challenges:  Set up of the Regulatory Affairs department with local procedures in line with current regulations and requirements
Our Solution: On -site placement allowed the consultant to understand and identify the global procedures and system in the company. They were able to then identify the local requirements and the procedures that needed to be put in place. The development of local procedures was done with particular attention to Marketing Authorisation compliance requirements supported by previous experience.

Project: Quality Management System (ISO 13485) pre-registration audit
Client: German branch of multi-national medical device company
Challenges:  A pre-inspection audit was required in line with ISO 13485 and medical device regulatory requirements to cover design and manufacturing activities across two sites in Germany. Language requirements were English/German.
Our Solution: On -site pre-inspection audit was carried out by one auditor over two days. We were able to fulfil client requirements and expectations by providing a registered lead auditor who had substantial knowledge and experience of quality management systems and IVD regulatory requirements with the added benefit of speaking the local language. Certification was subsequently successful.

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