TÜV Product Service Medical Testing Times : May 2008
2008 marks the return of the ‘Medical Testing Times’ – a quarterly newsletter to select Medical persons within the industry from TÜV Product Service. This newsletter is designed to keep you informed about changes within the industry – updates to requirements, new services we offer, events we are exhibiting at and other relevant news.
New ISO 17021: 2006 accreditation requirements affecting audits
The end of the transition period for EN ISO/IEC 17021: 2006 (Conformity assessment. Requirements for bodies providing audit and certification of management systems) was on the 1st May 2008. This standard covers the requirements for certification bodies and the principles of management system certifications within an organisation, (e.g. ISO 9001 / ISO 14001 for Quality or Environmental Management Systems, among other standards). As with all accredited Certification Bodies, we are required to follow this standard and to implement these changes within our certification systems. Two of the more significant changes concern the requirement for certified companies to in inform their certification body of all significant changes (including legal, organisational, management and ownership as well as things such as new production lines) and to provide a written response to minor non-conformities/observations to the lead auditor soon after the audit (these were previously followed up at the next annual audit).
TÜV Product Service recruits a new Senior Medical Device Specialist
Norman Richardson joined the Medical Health Services team at Octagon House on the 1st May 2008. Norman is an Electrical Engineer with over 30 years’ experience in the world of medical devices. His previous experience includes working for the Department of Health (now called the MHRA), for two notified bodies and in industry. Norman brings expert specialist knowledge in the assessment and testing of active medical devices.
In contrast, after two years of working for us, Dr Carol Bleakley one of our Lead Medical Auditors, left TÜV Product Service at the end of April to go back into industry - we wish her all the very best in the future.
REACH
The European Regulation REACH on the safety of chemicals imported into the EU could affect your business later this year. This could have a big impact on the availability of chemicals used in your production processes if your chemical suppliers have not pre-registered their substances before the 30th November 2008.
The REACH (Registration, Evaluation and Authorisation of Chemicals) regulation came into force on 1st June 2007 and has the objective of assessing the impact of substances on human health as well as on the environment. All existing as well as new substances need to be registered. More hazardous substances may be restricted in the future or require special authorisation for use.
Open Day at our Head Office in Fareham
This year’s Open Day at Octagon House will be on the 4th June, where guests will be able to tour our state of the art testing facilities and listen to many different presentations on relevant technical topics, while at the same time enjoying a boat trip and buffet lunch around the Solent. If you are interested in attending our Open Day, please register your interest by emailing Rob Greenwood on rgreenwood@tuvps.co.uk or phoning +44 (0)1489 558224.
Events
TÜV Product Service completed its first Quality Systems training course for Hospital Sterile Services Departments on 2nd – 3rd April and is now planning the next course, which has been tentatively scheduled in Ireland later this year. Please contact us for more details.
In January, Jeff Vest, spoke at the Informa conference in Holland on the changes to the Medical Devices Directive and, in February, Henry Sibun spoke on the changes to the Sterilisation Standards at MEDTEC UK in Birmingham. Angus McLean exhibited at the Chartered Quality Institute’s Medical Device Quality Group event on changes to the Risk Management Standard, ISO 14971:2007, on 29th April in London.
Other events that members of our Medical and Health Services team are attending and/or speaking at later this year include:
Henry Sibun and Angus McLean will exhibit and hold a table-top seminar at the ABHI Medical Innovations Forum on 25th June in London. Visit the following website for more details:
http://www.medical-innovation.net/
Henry Sibun is chairing and speaking on the first day of the Informa Life Sciences’ ‘Medical Device Summer School’, on 16th – 18th July in Cambridge. Visit the following website for more details:
http://www.iir-events.com/IIR-conf/LifeSciences/EventView.aspx?EventID=1644
TÜV Product Service invests in new GTEM Cell equipment
TÜV Product Service has recently invested in a GTEM Cell for which we will shortly be offering an opportunity to perform “quick-check” tests both Radiated Emission and Radiated Immunity. This new service would be beneficial to customers who wish to carry out investigatory and development Electromagnetic Compatibility (EMC) testing on their products in the design phase.
Past experience has shown that many products fall short of the Electromagnetic limits laid down for their product type as they are generally engineered for functionality (with less attention paid to their subsequent EMC profile). The ‘GTEM Experience’ will provide a suitable confidence level during the design stages and prior to final production. With its quick-check ability, it is an ideal opportunity to ensure that the product is on track to pass formal EMC testing at the first attempt.
Useful Links
Standards Harmonised against the Medical Devices Directive:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
Guidance documents from the European Commission:
http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm
