Prominent Global Medical Device Company


About the Client
A prominent global medical device company in the electrophysiology market. The client engaged Safis Solutions as their virtual regulatory department following unanticipated employee turnover.


The Client’s Needs

• Support of an ongoing clinical study

• Management of FDA 510(k) submissions, both under review and planned for new products

• Renewal of product licenses in China

• Quality System evaluation/improvement to facilitate successful regulatory inspection outcomes


The Safis Solution
The Safis team integrated into the Client project teams and took the lead in project activities. A Safis VP assumed the role of acting VP of Regulatory & Quality (onsite with the client) to drive progress.

 Safis, with support from the Client Executive team, facilitated adoption of a quality culture within the organization which has also improved the efficiency and effectiveness of business processes. Examples of successful outcomes from Safis engagement with the Client include:


• A clinical study protocol amendment that was prepared, submitted and approved by the FDA, which allowed the study to complete enrollment and meet all endpoints

o The product was approved in timely manner upon completion of the clinical study

• Agreement with the FDA on pre-clinical data to address questions on the submission, which lead to clearance of the product for marketing

o A total of five FDA clearances were ultimately obtained over a three-year period

• Renewed CFDA licenses, along with an additional product approved for the Chinese market

• Quality System improvements and a quality culture was embraced by the organization, with the following outcomes:

o Most recent Notified Body audit contained no Non-conformances

o Most recent FDA inspection (2016) had no Form-483 Observations


  With Safis support, market clearances in Japan, Canada, and Australia were obtained. Additionally, Safis updated the European Technical Files and Design Dossiers to support the introduction of new product enhancements. The Client has been extremely pleased with the services and results achieved by the Safis team, which have added real value and contributed to their overall success.


About Safis Solutions, LLC
Safis Solutions is a regulatory compliance consulting company serving pharmaceutical, medical device, diagnostic, and biotech companies globally. Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, IT services, auditing. Safis Solutions focuses its efforts on assisting the life sciences industry in meeting regulatory and quality standards expected by global health authorities. By offering a wide array of services, through a nimble internal structure, we are able to serve clients of all sizes. From tactical execution for our larger clients to full service strategic partnerships, we can adapt to serve our client’s needs.
At Safis Solutions, we understand that there is more to your work than gaining and maintaining your products approval from Global Health Authorities. It’s about improving quality of life for patients! That’s why we provide effective solutions to expedite the necessary processes which enable patients to access the diagnostic and therapeutic products that improve or save their lives.


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