MEDICAL DEVICES

Keeping your products compliant and innovative

Medical device manufacturers are under increasing pressure to bring innovative, fully compliant products to market faster, with higher quality and lower cost margins. Delivering high-quality products on time in strictly regulated industries like yours can challenge even the most well-organized company. Our team has comprehensive experience in the full spectrum of medical device development processes, from underlying regulatory and consensus requirements, to VNV through to product and service realization and sustainment.

WHERE WE CAN HELP

YOUR CAPA BACKLOG IS INTERFERING WITH PRODUCTIVITY

Our consultants can rapidly integrate into your remediation teams to reduce your CAPA load. We specialize in root cause analyses to drive long-term solutions to prevent recurrence.

YOUR PRODUCTS NEED SUSTAINMENT

Our team can deliver on critical elements necessary for sustaining existing products for revised technical standards, RoHS compliance, labeling updates, usability, and more. This frees your core staff to develop new products.

NPI NEEDS A KICKSTART

Our systems and software engineering experience can help you early in the
NPI process to identify and document all new product requirements while you concentrate on your core focus.

YOU NEED A TECHNOLOGY CHANGE AGENT

Marrying legacy systems or programming languages with today’s technologies can be difficult. Our experts can guide these technology changes to help your team stay current with changing product and market demands.

OUR MEDICAL DEVICE EXPERTISE

Base2 helped our customer migrate an innovative imaging device accessory from lab to production on a battery-operated tablet, running an embedded operating system and scripting language. We developed a new software architecture that enabled tracking of device state, such as battery life, and optimized performance to swiftly display images.

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Keys to Developing Safety-Critical Software

The true key to safer software is not requirements validation, but careful, reasoned application of systematic, incremental, iterative techniques applied to every level of development. This is not a mysterious process; safe complex systems are only built on top of safe, simple ones. After complexity becomes unbounded, no level of after-the-fact inspection, testing, or documentation is sufficient to rein it in again.

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CAPA REMEDIATION FOR DEVICE ACCESSORY RELIABILITY

A medical device manufacturer of Class III life-saving devices had two Corrective and Preventative Actions (CAPAs) that had been outstanding for over a year and a half. The company needed to have the CAPAs resolved to ensure that product elements in question were compliant with all pertinent regulations and allowed to continue shipping.

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