The ISO 13485 standard is the medical device industry’s most widely used international standard for a Quality Management System (QMS). IoMT Solutions, powered by Back Thru The Future, has been helping medical device manufacturers remain compliant for over 30 years.
Developing and deploying a QMS that meets the requirements of this standard is necessary to commercialize your devices in global markets. Medical device manufacturers who adhere to ISO 13485 standards have an easier time addressing the EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR).
What You Need To Be Compliant
ISO 13485 standard facilitates reduced safety and legal risks. Certification helps companies get recognized as more reputable, trustworthy providers because it is an internationally recognized standard.
The standard contains specific requirements for manufacture, installation, servicing, and end of life tracking of medical devices, including:
- Implementation of a Quality Management System with several enhancements
- Risk Management approach to product development and product realization
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
How We Help
Certification requires a risk-based approach for control of external providers of services. Service providers of high risk processes will require a higher level of control in evaluation and selection. These risks are in reference to the safety and performance of the medical device, however risks related to end-of-life processes also need to be considered. Destroying devices at end-of-life will protect you from data breaches, unauthorized use, and the secondary market.
IoMT Solutions Compliance Library
Our Compliance Library™ allows our clients to access all of their certifications and documentation 24 hours a day. Records are maintained for each individual project and identify the location and date of the disposal. The Compliance Library™ is fully searchable, which gives you the ability to find the disposal records of a single asset.
Certifications:
IoMT Solutions, powered by Back Thru The Future, is a fully licensed and certified facility. Our strict operational, data security, and environmental standards are unmatched.
NJDEP Class D License
US EPA Registration
NAID AAA Certification
PCI DSS Certification
NIST Compliant
ISO 9001:2015 Certification
ISO 14001:2015 Certification
ISO 45001:2018
R2 Responsible Recycling
NJ Business License
NY Business License
NJ Small Business Enterprise
WBENC
WBE Certification
WOSB CertificationGoldman Sachs 10KSB Alumni