Article | September 20, 2022

How Process Digitization Accelerates Northeast Scientific's FDA Compliance

By James Jardine

fda-approved

In a life sciences industry that is hyper-focused on saving money, companies that provide innovative ways to reuse or repurpose single-use medical devices (SUDs) enable providers to reinvest cost savings into delivering better health care. Yet, without the same established roadmap to compliance that many medical device companies enjoy, the regulatory path is uniquely difficult for trailblazing remanufacturers.

Northeast Scientific, the market leader in high-end peripheral vascular catheter remanufacturing, has reprocessed over 650,000 devices – but if its latest regulatory achievements are any indication of success, the reprocessing leader is just getting started.

Recently, Northeast Scientific received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first and only reprocessed laser atherectomy catheter in the history of reprocessing, the Philips Spectranetics 0.9mm OTW Turbo-Elite. Yet another FDA clearance is expected sometime in the third quarter of 2022, and the company has multiple other products in the pipeline for 2023.

Considering the amount of documentation generated for each device, Northeast Scientific believes they couldn’t have achieved these regulatory accomplishments without first having digitized and integrated our quality and manufacturing processes with MasterControl.

Northeast Scientific initially implemented MasterControl Quality Excellence and Manufacturing Excellence solutions as part of a holistic effort to scale operations while maintaining the highest levels of product quality and compliance with evolving regulations for remanufactured products. The transition to a fully digitized system has resulted in dramatic boosts in overall efficiency, productivity, and speed to market. Since implementing MasterControl, Allmendinger says that standard operating procedures (SOPs), validation,, and training can now be completed in one-third of the time it used to take.

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