Certification Services for the Medical Sector

LSA is proud to be the local Israeli representative of Intertek - The global leader of Certification and Quality & Safety Testing.

For medical manufacturers seeking new market-entry opportunities, reaching those markets quickly and cost-effectively can be a challenge. Conformity with varying regulatory requirements is most often a prerequisite.  Those who want to compete effectively should also have in place a properly implemented and maintained quality management system (QMS). It can be difficult to keep track of these compliance requirements without an insider's help.
Intertek can provide you with the industry-specific expertise you need to gain market access and maximize revenue potential. Intertek is your single source for certification and testing services, regardless of your target market:

• ISO 13485:2003 provides QMS requirements for medical device manufacturers. Many regulatory authorities around the world have adopted (or will adopt) this standard.
• ISO 14971:2007 provides requirements for risk management systems. Many global standards and regulatory requirements now include references to this standard and require you to have a documented risk management system in place.
• For market entry in the EU, Intertek's three Notified Bodies (Amtac / Intertek Semko and Intertek Testing and Certification ltd) can provide you the assessment needed under the Medical Device Directive (MDD) for CE marking. 
• In the US, Intertek is accredited by the FDA to conduct inspections on their behalf under the Accredited Persons (AP) Inspection Program.  Intertek is also accredited by the FDA to conduct third-party 510(k) reviews. 
• For manufacturers applying for device licenses in Canada, Intertek is recognized by Health Canada to provide the ISO 13485 certification required under the Canadian Medical Device Conformity Assessment System (CMDCAS) program.
• For manufacturers in the EU seeking market entry in Taiwan, our Taiwan Technical Cooperation Program (TCP) allows you to use an ISO 13485 certificate from Intertek to satisfy many of Taiwan's requirements, dramatically reducing the time to market in that area. 
• Through Intertek's partner certification body, Spindler Associates, Intertek can provide quality system (GMP) assessments required to satisfy the Pharmaceutical Affairs Law (PAL) in Japan.
• The Dental Appliance Manufacturers Audit Scheme (DAMAS) is a voluntary quality management scheme for dental laboratories, helping them meet the requirements of the MDD and the Medical Devices Regulations (MDR).

Intertek's knowledge, expertise, experience and industry insight promote an efficient certification process from start to finish.  Intertek will use its know-how to help you achieve your product and system certification smoothly and cost-effectively.

For further information on System Certification Services, please visit http://www.intertek-sc.com

For further information on Intertek's quality and safety testing, please click here , or visit www.intertek.com/med-pharma/