Medical Device and Pharmaceutical Product Development and Compliance

Navigating Product Development and Compliance

Helping to navigate product development and compliance for the life science industry. Our SaaS-based solutions enable customers to structure their data and automate compliance processes with built-in quality templates and automated generation of deliverables to save time and money, delivering their products to market faster with less risk.

Ben Higgitt

Ben Higgitt is the Engineering Technical Lead at Cognition Corporation, a SaaS company that develops product development and compliance solutions for the life sciences industry. He is passionate about aligning technology with constantly evolving standards and regulatory requirements and works closely with customers, industry leaders, and regulatory experts to challenge historical precedent and design solutions that go beyond today’s requirements.

Blog Feature

Medical Device | Risk | Risk Management | ISO | FMEA

Complying with ISO 14971:2019

By: Ben Higgitt
August 11th, 2020

SEPARATE RISK MANAGEMENT AND FMEA FOR BETTER MEDICAL DEVICE DEVELOPMENT. The below is an excerpt of the article originally published on MDDI. FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by failures alone. A product may never fail, but there are still potentially many other risks.

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