ISO 13485 Certification - Chicago - New York

ISO 13485 is an internationally accepted quality system standard for medical device industry. The latest version of the standard is ISO 13485 : 2016. Any organization having the scope of manufacturing, design or servicing of medical device can implement ISO 13485.

ISO 13485 is a mandatory requirement for CE Certification, after technical file approval the notification body will conduct an onsite audit to assess the level of ISO 13485 implementation. Notification body will issue the CE Certificate only if the ISO 13485 implementation is satisfactory.

ISO 13485 Certification is not required as per the standard, but most medical device importers and distributors ask for a third party ISO certificate as a proof of proper ISO 13485 implementation.

GMP (21 cfr 820 ) is a mandatory requirement for US Medical device companies, implementation of ISO 13485 will help to cover more than 90% of GMP requirements. An integrated quality manual and procedure will help US companies to comply with both GMP and EU requirements.

ISO 13485 Consultants

Our experienced ISO 13485 consultants will help you to prepare and implement an integrated quality system for ISO and GMP (21 cfr 820).

Our service includes.

  • Prepare Quality Manual
  • Prepare Quality System Procedures
  • Assistance with ISO/GMP implementation
  • Certification Body audit
iso 13485 certification process

Our Consulting Services includes

For more information, Please contact us with detailed information.