ISO 13485 is an international standard adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused on ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. 

Medical Device Single Audit Program

E & E medicals best Consulting practices is based on assisting small, medium and large companies in the healthcare industry. All facilities that engage in the production, packaging, and distribution of medical products need QMS for ISO 13485 certification. Achieving this objective needs your team to work with a competent ISO 13485 consultant. Our consultants provide detailed techniques on standards intent as ISO 13485 compliant Quality Management System (QMS) is implemented and the same time creating confidence in end users, government, statutory and regulatory agencies with answers to all questions from Regulatory and Certification Body Auditors.

Appointing E& E Medicals as ISO Consultant

Organizations participating in one or more stages of the medical device Lifecycle, Suppliers or External Parties who provide products or services required for ISO 13485 certification. Such organizations include:

  • Design and Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing
  • Components
  • Sub-assemblies
  • Medical devices
  • Sterilization services
  • Calibration services
  • Distribution

The Medical Device Single Audit Program commonly called MDSAP is based on the principles of ISO 13485, which remain part of the audit requirements. Within the framework of the Medical Device Single Audit Program (MDSAP), the quality management system of organizations can be audited for potentially five different markets (Canada, USA, Japan, Australia, Brazil), it is important to know that, at a minimum, the provisions of ISO 13485 will be included in the audit criteria along with the relevant regulations for you to market your products in these countries.

Your organization can be audited by a third-party organization called Registrar, such as TUV, who will certify your organization to this standard. It will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820. All Medical Device finished product and component manufactures, including Software and Medical Device Developers, have to meet with ISO 13485 Certification requirements. ISO 13485 Certificate will be issued by an accredited third-party if you comply with the Medical Device Quality Management System. E & E Medicals and consulting will assist in the training, documentation, implementation, internal audit, and other related services to ensure full compliance with the EN ISO 13485 standard.