is the online magazine of BSI Group, highlighting the vital role that standards play in today's business environment by helping organizations improve quality, save money, reduce risk and be more sustainable. Features include interviews with leading business figures, as well as news on the latest developments in management systems, standards, testing, healthcare and certification.
Jumping the pond
29 Oct 2007
Topics: Medical devices, CE mark, USA, Americas
BSI Product Services Healthcare has just launched a 90-day CE marking programme, CE-90, aimed at giving healthcare customers faster access to the European market. CE marking offers medical device manufacturers worldwide an opportunity to break into the European market, which can be a challenge, especially with highly regulated products and services in areas such as healthcare and medical devices.
"BSI's target is to complete design dossier reviews in 90 working days or less," says Linda Vasquez, senior marketing manager, BSI Product Services Healthcare in USA. "BSI has assembled a team of full time medical device experts from industry so that we are fully resourced to meet and deliver device manufacturers' expectations for timely reviews."
The CE-90 programme has been developed especially for products needing design dossier reviews, detailed reviews of the technical file of a specific product. This includes Class III, highest risk devices, such as those in contact with the heart, brain, circulatory system or central nervous system, and often implantable.
For more information: www.bsigroup.com/oct07medicaldevices
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A little bit extra for Kitemark® bodyshops and garages
It's all well and good for an automotive bodyshop to earn the Thatcham BSI Kitemark® for Vehicle Body Repair, but it won't have as much impact if potential clients don't know about it. As a consequence, BSI decided to offer an Extras marketing toolkit to bodyshops and garages that have earned the Kitemark.
UK film industry pioneers sustainability standard developed by BSI
The British film industry, in conjunction with BSI, is taking the lead in the global entertainment market with the announcement at the Cannes Film Festival of a new British Standard that will improve the industry's environmental, social and economic impact. For example, in London alone, screen production accounted for 125,000 tonnes of carbon emissions in 2009, 40% of which came from studios and 28% from TV and film production.
BSI is planning an informal free lunchtime roundtable in central London on 10 December 2009 to explore how small businesses and their trade bodies can work more effectively with standards. Places are limited so to register your interest or request more information, please email bsi.survey@bsigroup.com or call +44 (0)20 8996 7750.
Rising waters: revising PAS 1188
For those living in areas that are prone to flooding, having the right protection resources available is essential. While images of emergency sandbags holding back rivers of water may fill the media, there is a much wider range of products available for flood protection.
Until now, there has been no strict guidance in the UK relating to how audiovisual (AV) installations are carried out. This includes everything from computers and projectors to interactive whiteboards, plasma screens and loud speakers. For AV installation companies, processes can vary significantly.
Question: Are health and safety issues at risk of being lost in the current financial turmoil?
When business isn't going well - whether it's due to a recession or simply because a company is going through a slow patch - there is a temptation to cut costs by cutting corners. Instead of treating an issue like product and consumer safety as vital to a organization's growth and reputation, it can become just another expense or regulatory requirement.
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