Ironstone Product Development (IPD) has received ISO 13485:2016 certification for its medical device development quality system. This ISO 13485 certification reflects IPD’s ability to deliver turnkey medical device development projects for devices of all classes and types. IPD’s product development system is both ISO 13485- and FDA QSR-compliant and employs a risk-based approach to system and software development, ensuring the resulting medical devices are safe and effective. IPD’s product development includes overall system development, as well as software, mechanical, electrical and industrial design. This ISO-certified product development system complements and supports IPD’s other service offerings in regulatory strategy, clinical study design, and execution, as well as quality system setup and support.
"The ISO 13485:2016 certification, combined with our regulatory and clinical services, enables us to deliver a full turnkey solution to our clients. Our regulatory expertise ensures that our product development projects meet our clients' regulatory and clinical goals." Joel Ironstone-President and Principal Consultant
About Ironstone Product Development (IPD)
IPD is an ISO 13485:2016-certified medical device consulting company. Initially founded in 2014 to provide clinical and regulatory strategy, the company has since expanded to become Canada’s only fully integrated medtech consulting company offering clinical trial design and execution services, QMS setup and consulting, as well as full turnkey product development. The IPD consulting team has a combined 100 years of experience in medical device development in projects ranging from Class III implantable vascular devices to exempt wellness applications. IPD’s work has resulted in dozens of successful 510(k)s, De-Novos, PMAs and worldwide regulatory approvals for projects in critical care, cardiology, neurology, imaging, in-vitro diagnostics, women’s health, gerontology, ophthalmology, and orthopedics.
Contact:
Joel ironstone
President
Ironstone Producer Development
Office: (416) 783-2133
www.ironstonepd.com
Press Release Service by Newswire.com
Original Source: Ironstone Product Development Receives ISO 13485:2016 Certification
