We get to be a part of revolutionary products in science and medicine that solve important problems and that excites us. Our medical device consulting business plays to our strength as Blue Pearl is able to bridge our manufacturing business with our healthcare & medical practice. We assist small and large clients in regulatory and FDA strategy, product manufacturing and market strategy.
Below is a small sample of the services we perform for our clients.
Click here to learn more about all of the services that we offer.
Blue Pearl provides regulatory consulting services for Medical Device companies that are required to comply with FDA regulations. Navigating the FDA regulatory requirements can be very challenging. We have experience with Class I thru Class III medical devices and all aspects of the FDA approval process – pre-market notifications (PMA’s), 510(k) submissions, IDE’s. We also offer clinical trial consulting services to medical device manufacturers. We understand the nuances various specialty areas and are able to advise and design clinical protocols for the approval process.
Whether your goal is to bring a new product to market or to modify an existing product line with a latter generation device, Blue Pearl consultants work from inception to approval, developing a comprehensive strategy to avoid delay and unnecessary expense while ensuring your FDA submission is timely and complete.
There are numerous things that can complicate and frustrate the development and introduction of a new medical devices, click here to learn more about Blue Pearl’s experience
Blue Pearl works with clients on new and existing production processes for the manufacturing of medical devices. With the continued growth of the medical device market, companies are venturing into innovative development and applications. We have helped companies evaluate and develop a manufacturing strategy – including evaluating and vetting contract manufacturers for the entire or partial manufacturing portion.
Additionally, the FDA approval process includes the manufacturing process detail, GMP (Good Manufacturing Practice), and requires more extensive process validation. This also includes looking at the best practices and the use of reduced contamination areas / Clean Rooms.
There are numerous things that can complicate and frustrate the development and introduction of a new medical devices, to learn more about Blue Pearl’s experience click here.
With expertise in finance, marketing and sales, Blue Pearl is well positioned to formulate a commercialization strategy for our client’s device(s). We also believe, part and parcel, the market strategy, should include a comprehensive medical device reimbursement strategy. It is a key tool available to companies to align with investor and management expectations for increased margins and profitability. Blue Pearl brings expertise in:
Code Creation –
ICD-10, CPT, HCPCS
Payer Group Strategy
Timelines for new codes
Click here to learn more about our work.