Medical device companies that still need to meet the looming Medical Devices Regulation (MDR) deadline for the products they sell in Europe now have a one-stop resource to ensure they are ready and in compliance.
“The MDR Transition Program from Boulder iQ will take companies through every step required for MDR compliance, in advance of the May deadline,” says Jim Kasic, chairman and founder. “Larger companies may be ready, but many small and mid-size companies – innovators that are bringing critically needed medical devices to the market during a pandemic – need additional assistance right now,” he explains. “The process to bring those products into MDR compliance takes massive amounts of man hours and effort. Depending on the company, product and timeline, the MDR Transition Program could potentially save a device developer up to hundreds of hours of time.”
The Boulder iQ MDR Transition Program includes a step-by-step, checklist approach to:
- Evaluate:
– Gap analysis on current documentation
and systems
– Technical documentation
– Declaration of Conformity
– Clinical Evaluation Report
– Quality management system
– Agreements with authorized representative,
importers and distributors
- Map: Determine plan based on gap analysis results
- Execute: Update, revise and develop documentation, systems and procedures
- Transition: Implement new and updated documentation and systems
- Train: Learn the MDR and the organization’s revised documentation, revised systems and new procedures
The extended deadline for the MDR has helped many companies prepare, says Kasic, but the impacts of the ongoing COVID-19 pandemic have stymied efforts of many others. In addition to supply-chain issues, many employees are working from home (or are unable to work at all), and virtual audits have even replaced in-person ones in some cases.
“The Boulder iQ MDR Transition Program is one more way we are working to make sure every medical device developer can get their product to the market during this pandemic,” concludes Kasic. “Medical device companies can continue focusing on development of critical products, while leveraging Boulder iQ’s experience and expertise in MDR compliance.”
About Boulder iQ (http://www.boulderiq.com)
Boulder iQ is an expert contract consulting firm offering design engineering, development, and turnkey manufacturing for consumer, high-technology and medical products, and regulatory, clinical and quality compliance services for medical device and in vitro diagnostic companies. Based in Boulder, Colorado, the company is ISO 13485:2016 certified through Boulder BioMed.
The company’s Boulder Sterilization division provides ethylene oxide sterilization services. Boulder iQ’s Boulder Medical Device Accelerator provides equity investment in start-up companies seeking product development services, expert mentoring and infrastructure support.
Contact: Aimee Bennett, Fagan Business Communications, 303-843-9840, [email protected]
