Between expensive consultants and Excel spreadsheets, most medical device companies we speak to are struggling to manage their compliance to various consensus standards like IEC 62304 (software), IEC 60601 (electrical), ISO 10993 (biocomp), and ISO 11137 (sterilization), not to mention ISO 13485 (quality) and ISO 14971 (risk). So we decided to build an all-in-one compliance management hub which helps organize compliance tasks like evidence collection, drastically reducing the time it takes to get and prove compliance. We’ve even got template checklists for many common consensus standards.

Reach out if you’d like our limited trial access to the compliance hub!

A Labyrinth of Compliance

In an era of budding innovation in medtech (fun!), the FDA was recently forced to remind device makers about the sanctity of testing data (not fun!) as it relates to third party labs.

From the announcement: “In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable.”

This specific issue is part of a larger problem. Amidst hundreds of consensus standards that the FDA recognizes, from biocompatibility to electrical safety, the challenge for medical device manufacturers isn't just to innovate but to navigate a labyrinth of compliance while doing so. Demonstration of conformity with FDA-recognized standards in premarket submissions is encouraged by the agency and can help with the review process. But most medical device companies don’t know where to start, let alone how to execute.

Source: FDA Consensus Standards Database

No Standard Approach

As we met with hundreds of teams over the last year, we noticed that the way the companies navigate these standards is time-consuming and prone to errors. First, many teams don’t have a great sense of which standards they should even consider. And for the standards that are to be considered, the process of deciphering dense regulatory documents can often feel overwhelming and confusing. Further, actually implementing processes or product requirements to satisfy standards, finding testing facilities, generating conformity evidence, and staying up to date on changes to standards are each Herculean tasks.

Most teams are managing this with a mix of consultants and testing labs (often improperly vetted), Excel spreadsheets, intuition, and probably many prayers.

Example standards used in actual 510(k) for simple EEG device

Going beyond 13485

While Ultralight already helps medical device teams establish processes for requirements and quality management, and thus establish conformance to ISO 13485 (quality) and ISO 14971 (risk), we saw a major opportunity to serve customers by helping them conform to additional consensus standards.

So we decided to build an all-in-one compliance management hub which helps organize compliance tasks like requirements mapping and evidence collection, drastically reducing the time it takes to get and prove compliance. We’ve even worked with experts on specific standards to build template checklists for many common consensus standards.

Select Screenshots from Ultralight’s Compliance Hub

While we’re primarily offering access to the compliance hub to existing customers who leverage Ultralight’s platform for requirements and quality management, we’re currently offering trial access to just the compliance hub for a small cohort of early adopters who would like to provide feedback. If you’d like to better manage your conformance to consensus standards, please reach out or schedule a demo.