M2S: FDA Registered Establishment and ISO 13485:2016

Quality assurance is a critical dimension of all M2S production activities. Validation and certification procedures are applied to every processed case. The FDA granted clearance to market Preview in 1996, subject to the relevant FDA regulations. These regulations include the requirement that the development and manufacture of the device be conducted in compliance with FDA Quality System Regulations in an establishment that is registered with the FDA. M2S became certified to ISO 13485 in 2006 and undergoes annual assessment audits to ensure continual compliance. M2S maintains a sophisticated quality assurance system at its production facility that is designed to encompass a risk based approach to both FDA and ISO requirements for the manufacture of medical devices.

Health Insurance Portability and Accountability Act (HIPAA) Compliance Statement

As a healthcare provider, M2S is committed to compliance with the requirements of the Health Insurance Portability and Accountability Act (HIPAA). These regulations pertain to the security, electronic data interchange and confidentiality of patient health information. As a part of its overall quality system M2S has established a formal, written program for HIPAA compliance to ensure appropriate protection of patient protected health information (PHI) is maintained between M2S and its customers. To meet the requirements for patient privacy M2S employs such systems and techniques as:

  • Advanced firewall security
  • Sophisticated data encryption algorithms
  • Password protected system access
  • Restricted visitor access
  • Virtual Private Networks (VPN)
  • Intrusion detection systems

These mechanisms undergo routine evaluation and upgrade as technologies related to security and privacy improvements.


Protecting data security is paramount

At M2S, we understand the importance of security. To ensure security, we not only follow HIPAA guidelines, we have also certified to the EU-U.S. Privacy Shield program. In addition, we use military-grade components to protect data, including 1024-bit RSA public-key encryption and 256-bit Advanced Encryption standard (AES) data encryption.

If you would like more information on M2S’s HIPAA compliance efforts, please contact our HIPAA Compliance Officer at (603) 298-5509 or hipaa@m2s.com.