Quality Management System Development and Regulatory Support for Medical Device Facilities

Quality Management Systems (QMS)

Health Care Informed can assist in an organisation's understanding, implementation and development of an effective Quality Management System that meets the required regulations with a continued focus on the business activities.

The QMS, including all procedures and support documents, can be developed to meet the applicable requirements, including but not exclusively:

  • MDD 93/42/EEC and 2007/47/EC – incorporating relevant MEDDEV’s and guidance documents, FDA QSR’s.
  • Canadian Medical Device Regulations.
  • ISO13485:2003 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
  • ISO 14971:2007 – Application of Risk Management to Medical Devices.

Other services provided by Health Care Informed in relation to the QMS include:

  • Medical Device Vigilance System development and application, including management of Field Safety Corrective Actions.
  • Guidance and implementation of Post Market Surveillance Activities.
  • Required controls to ensure Manufacturing Compliance.
  • Completion of Quality and Regulatory Gap Analysis against applicable national and international standards.
  • Guidance on development of Outsource Models and introduction to proven tools for successful outsource partnerships.

Product Approval and Clearance

To gain entry to the market, product approvals, market clearances and licences must be completed via device submissions to the Regulatory Authorities. Health Care Informed can provide assistance in the development and review of submissions for Europe, the US, Canada and the wider international market. With experience in Class I, II (a & b) and III devices, we can provide effective guidance to ensure reduced time to market for your device.

Auditing

Health Care Informed can provide qualified auditors to complete Internal and Supplier Audit activities for your company or prepare your company for audit by external parties. Audit activities will be completed in accordance to ISO19011:2002 Guidelines for quality and/or environmental management systems auditing. Assessment can be completed against European, US and Canadian Regulation as required. Reviews can also be completed on 510k submissions and Technical Files.

Risk Management

Risk Management has become one of the primary areas of focus for regulatory authorities and Notified Bodies and is one which must be initiated from early in the device development process throughout the product lifetime. Health Care Informed can assist in the implementation of proven Risk Management Tools which meet the global regulatory requirements, including ISO 14971:2007.

Training

Training can be provided for the following:

  • Internal or External Auditing practice – completed in accordance to ISO9011:2003 to meet requirements of ISO13485:2003.
  • Introduction and application of Medical Device Directives 93/42/EEC and 2007/47/EC, FDA QSR’s, Canadian Medical Device Regulation, MEDDEV’s, and ISO13485:2003.
  • ISO14971:2007 Medical Devices – Application of Risk Management to Medical Devices.
  • Any element of the QMS services provided by HCI.

For more information contact us today info@hci.ie