ISO 13485: 2003 certification indicates that Preventice has met the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It serves to harmonize regulatory requirements and facilitate compliance with the requirements to customers and global regulators.
"ISO 13485: 2003 certification is a globally recognized standard that signals to our customers, strategic partners, and the broader industry that Preventice abides by the highest standards for quality and manufacturing," said Jon Otterstatter, co-founder, President, and CEO of Preventice. "There is a rapidly growing appetite for remote monitoring technology as a solution to current and future health care needs, and the ISO certification demonstrates our adherence to industry standards and sets the stage for us to expand our reach, providing a clinically sound solution in the BodyGuardian RMS."
ISO 13485: 2003 certification is a critical step in the process to receive CE mark approval for the company's BodyGuardian RMS. Developed in collaboration with Mayo Clinic, the BodyGuardian RMS uses sophisticated algorithms to support remote monitoring of individuals with cardiac arrhythmias. Preventice received 510(k) clearance from the U.S. Food and Drug Administration in August 2012, enabling the mobile health solutions company to market BodyGuardian RMS for use in detecting and monitoring nonlethal cardiac arrhythmias for ambulatory patients.
The ISO 13485: 2003 certification is based on ISO 9001. With the ISO 13485: 2003 certification, there is an emphasis on meeting regulatory as well as customer requirements, risk management, and maintaining effective processes. The certification dictates that risk management must be thoroughly documented and conducted throughout a product's entire lifecycle, from initial concept to delivery and post-delivery.
"We are being very deliberate and thoughtful in our efforts to create an environment of increased efficiency, improved design and process control, better product quality, and enhanced customer service for the BodyGuardian RMS," said Charlie Rector, Director of Product Operations for Preventice. "The ISO 13485: 2003 certification directly supports these efforts and provides the foundation upon which we can effectively expand remote patient monitoring to numerous world markets."
Preventice worked with British Standards Institution (BSI), an international business standards leader and European Union (EU) Notified Body, during the ISO 13485: 2003 certification process. Founded in 1901, BSI was the "world's first National Standards Body" and is responsible for originating many of the world's most commonly used management system standards. BSI works with more than 70,000 clients in 150 countries worldwide to help them adopt and cultivate best practices. BSI is a founding member of the International Organization for Standardization (ISO). In the EU, a notified body is an organization that has been accredited by a member state to assess whether a product meets certain predefined standards.
Preventice Inc., is a privately owned company and leading developer of mobile health applications and remote monitoring systems that connect mobile, home-based, and on-premise technologies to deliver continuous patient care across the health continuum wherever an individual patient might be. Applications from Preventice create a constant connection and exchange of data among healthcare providers, life science companies, and their patients. Current applications from Preventice address high-cost conditions and health management opportunities, including prescription medication management, cardiac care, sleep apnea, diabetes management, and migraine headaches. Preventice is headquartered in Minneapolis, with offices in Rochester, MN, and Fargo. ND.
Preventice Inc. has licensed the remote monitoring algorithms for the BodyGuardian Remote Monitoring System (BodyGuardian RMS) from Mayo Clinic. BodyGuardian RMS detects, records, and wirelessly transmits physiological data to support remote monitoring of nonlethal, cardiac arrhythmias in ambulatory patients. Data is transmitted to the Preventice mHealth platform, where it can be stored for later retrieval.
The BodyGuardian RMS sensor adheres to the patient's skin and is smaller than a cell phone, giving patients complete mobility and freedom to go about their normal lives without restriction. Physicians and medical professionals can securely view the captured medical information anytime, any place on devices such as the iPad, or online. Physicians can retrieve patient data and reports or choose to receive alerts based on changes in select biometrics.