Design and Manufacture

ISO 13485 – Certificate MD 82182

The Ennis facility is accredited to EN ISO 13485, which specifies requirements for a comprehensive quality management system (QMS) applicable to the design, development, production, distribution, and servicing of medical devices.
This forms the baseline for our facility QMS, upon which we add the requirements of jurisdictional quality system regulations and associated standards. Compliance ensures our devices meet the requirements for safety and performance, from the design process through production, to patient use, and eventual device disposal.

IEC 62304 Medical Device Software — Software Life Cycle Processes

Vitalograph’s software development process complies with the international standard IEC 62304 medical device software standard. This standard is a requirement for the development and maintenance of medical device software which includes software used on mobile devices, software intended as a standalone medical device, and software or firmware embedded within medical devices.
It is intended to cover the whole software lifecycle, from initial specification, safety classification, software development process, development process documentation, software maintenance, software risk management, configuration management and the software problem resolution process. Software development is included as a key component within the ISO 14971 process for medical devices risk management.

ISO 14971 Medical devices — Application of Risk Management to Medical Devices

Risk management is a critical component of any medical device manufacturer’s QMS, and Vitalograph conform to the ISO 14971 risk management standard across all elements of the QMS, including post production activities where data is fed back into our risk process to allow us to improve both device and process as necessary.

CE Marking – Certificates CE 00772 and CE 85553

The European Community recognized the need for standards on medical device safety and performance, and published the Medical Device Directives in 1995, laying down mandatory requirements for product safety and performance, with guidelines for ensuring safety even when no particular standards existed. Conformance to the requirements to permit the placement of the CE Marking on our devices is overseen by our Notified Body, BSI (2797), and by the Health Products Regulatory Authority (HPRA) in Ireland.
The new European Medical Devices Regulation 2017/745/EC, the MDR, will replace the Medical Devices Directive (93/42/EEC), the MDD, in May 2021 including a three year transition period. Vitalograph is working with our Notified Body and the HPRA to transition our QMS and our devices from CE Marking under MDD to CE Marking under MDR during this transition period.

As result of EU Amending Regulation 2023/607 published 20 March 2023, the EU Commission has extended the validity of certificates issued by notified bodies under EU Directive 93/42/EEC.  This extension to the end of the relevant transition period of 31 December 2028 applies to Vitalograph’s current EC Certificates which were due to expire after 19 March 2023, so that they now expire at the end of the relevant transition period.

Certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market.

| CE 00772 Certification  | CE 85553 Certification |

MDSAP Program – Certificate 700480

In 2019 Vitalograph received its Medical Device Single Audit Program (MDSAP) Certificate, following rigorous audits in our Ennis facility. The MDSAP program centres on adherence to the quality system regulations from each of the participating MDSAP countries. It provides a means by which medical device manufacturers can have a single audit program by designated 3rd party Auditors to prove compliance with the regulatory requirements of these countries.
Vitalograph’s QMS, device design and production are audited under MDSAP Program against the QSRs of The United States of America, Australia, Brazil, Canada, and Japan.