Press Release

RESULTS OF INDUSTRY'S 1ST QUALITY SYSTEM PARITY SURVEY ANNOUNCED - INDICATES SUPPLIER CERTIFICATION TO ISO 13485:2003 AT RECORD HIGHS

• Crimson research indicates 36% of medical device suppliers certified to ISO 13485:2003, additional 20% contemplating certification within 18-24 months
• Value of Quality System Parity cited as key driver
• Complete research synopsis available from Crimson here.

BOSTON, MA USA — April, 10 2007 — Crimson Life Sciences (a division of TransPerfect Translations) today announced results of the industry's first survey of quality system parity in the medical device industry. Quality system parity is the term used to describe equivalent levels of quality system certification between manufacturers and suppliers.

ISO 13485:2003 SUPPLIER CERTIFICATIONS AT RECORD HIGHS:

Crimson Life Sciences says its first-ever survey of supplier certification to ISO 13485:2000, indicates that "Control and risk management issues have made quality system parity an increasingly important prerequisite for medical device manufacturers and suppliers. This research indicates that ISO 13485 certification is growing at a significant rate," says Marc H. Miller, Crimson President. Complete research synopsis available from Crimson - send your email request to mmiller@crimsonlanguage.com.

According to the Crimson research (based on information from 429 supplier companies), quality system parity (i.e. supplier certification to ISO 13485:2003) among medical device suppliers is currently at 36%. Perhaps more importantly, certification among so-called nonexempt suppliers is at 55%—indicating the growing value attached to quality system parity.

Explains Miller, "Nonexempt suppliers are component suppliers whose products are not exempt from destructive in-coming inspection. These companies are not required to certify to 13485, because their product specs are validated as part of the manufacturer's acceptance activities. However, our research shows that these companies are certifying to 13485 in record numbers—largely because of the value manufacturers place on quality system parity."

INDUSTRY INTERVIEWS CONFIRM SURVEY RESULTS:

Interviews with both manufacturers and suppliers confirm the growing importance of ISO 13485 as a valuable quality system benchmark. Observes Tracy Omdahl, Manager of Quality & Regulatory Affairs at device manufacturer, Genicom, "75% of our suppliers are certified to 13485. For us, it's an important prerequisite."

EU Notified Bodies are also pushing manufacturers to consider quality system parity when they evaluate potential suppliers. Linda Wertz, Sr Mgr of Quality Assurance at Celera Corp, an Applera Business (Alameda CA), says that "Registrars such as TUV Rhineland are encouraging manufacturers to source from suppliers that are 13485 certified. Their belief is that if a supplier is certified to 13485, that should be sufficient for qualification without auditing."

As a result of manufacturer focus, suppliers are noticing an increased attention to quality system parity. Notes Chrissy Kling, QA Manager at AP Extrusion, "We are receiving dozens of calls a week and everyone is asking about certification to ISO 13485."

The Crimson study also shows that suppliers that certify to ISO 13485 have found real benefits beyond the obvious business opportunities. Adam Trenz, Quality Manager at Excel Medical Products, is guiding his company's current certification efforts. Says Trenz, "Certification to ISO 13485 means that very soon, we will be positioned to support our clients' dock-to-stock initiatives. We also know that incoming inspection is less burdensome with certification to 13485."

REGULATION & RISK MANAGEMENT DRIVE QUALITY SYSTEM PARITY:

Key factors in the growth of quality system parity are the risk management, process validation, and supplier control requirements of ISO 13485 and ISO 14971. In fact, section 2.6 of ISO 14971 defines the manufacturer as: "Natural or legal person with responsibility for the design, manufacture, packaging or labeling of a medical device, assembling a system, or adapting a medical device before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person himself or on his behalf by a third party."

In other words, from the standpoint of this critical risk management standard, the supplier and manufacturer are one-in-the-same. Obviously, this increases the burden of responsibility for the manufacturer—and the emphasis placed on the reliability of the supplier's quality management system.

According to published Notified Body guidance, suppliers of, "A part, material or service, which may affect the compliance of the device with the essential requirement," may come under special scrutiny for quality systems parity. Included in this definition are obvious suppliers, such as sterilization firms or contract manufacturers, as well as labeling translation companies.

Notified Body guidance also states: "Due to the compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an 'important outsourced service'...This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971."

SURVEY RESULTS POINT TO VALUE OF QUALITY SYSTEM PARITY:

Results of Crimson's survey indicate the value of quality system parity for manufacturers and suppliers. Explains Miller, "Manufacturers select suppliers who are certified to ISO 13485, because it makes their lives easier. There is less audit burden, improved risk management, and definitely increased supplier control. For the supplier, besides obvious client access, there are operational benefits and an easier time with CE audits -- leading to increased EU sales."

Given current regulatory and competitive pressure, the trend toward more widespread quality system parity is likely to increase, the Crimson study concludes.

VALUABLE MDD, IVDD, ISO & OTHER REGULATORY RESOURCES ONLINE:

About Crimson Life Sciences:

Crimson Life Sciences, founded in 1992, provides "Expertise in Translation for the Medical Technology Industries." Crimson is the only translation organization in the world to hold ISO 9001:2000 and ISO 13485:2003 certifications, plus an official endorsement to ISO 14971:2000. Crimson's work has been recognized as MDD-compliant by an EU Notified Body. Crimson clients include industry leaders such as Cook, Stryker, Chiron, Bio-Rad and Arrow International.

In 2005, Crimson merged with TransPerfect Translations (world's 3rd largest language service provider), to form the industry's premier life sciences practice. Clients enjoy access to the expanded process and technology resources of the entire TransPerfect family of companies, including software localization specialist, Translations.com. More information is available at the Crimson website: www.medical.crimsonlanguage.com.

Crimson's original founder, Marc H. Miller, continues to provide management guidance as division President and VP of Quality Systems for the entire TransPerfect organization. Miller received a BA in languages and literature from Harvard University and an MBA from the Scottish Business School in Stirling Scotland. While working as a Sr Research Fellow with the international strategy consulting firm of SIAR, he authored strategic assessments for European and US medical technology firms. Crimson's specialized approach to medical technology translation has also been featured in industry publications such as Medical Device & Diagnostics Industry, Medical Products Outsourcing, and Orthopedic Design & Technology.