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Medical Devices & Bioinformatics Consulting.

10/14/2026

“Think of AI as your intern who’s doing your heavy lifting.”

Becky Legare’s analogy for working with AI in a regulated environment: Let AI do the heavy lifting, allowing you to focus your expertise where it’s needed most. But always check its work.

That’s how we’ve historically approached our work, and it’s no different with AI: Trust but verify!

10/08/2026

Which is hardest with AI: proving it’s governed, accountable, or defensible?

At the recent MassMEDIC event, BSI was asked this exact question.

Samantha Sewlochan picked “defensible,” explaining: “Defensibility, to me, means being able to show that your controls and mitigations can hold up when your AI is challenged.”

She went on to explain that independent assessments add crucial credibility; providing far more weight than simply self-attesting that your organization is doing things right.

Warwick brings the consulting expertise to help organizations implement and operationalize trustworthy AI, while BSI provides independent AI Performance Assessment and the BSI Mark of Trust to assess the performance of the AI system and provide assurance that it is performing as intended and subject to ongoing monitoring.

10/01/2026

Quality System documentation review is a skill set, and it is not an easy one to master.

For years, reviewing a Quality Management System meant going page by page, printing documents, highlighting sections, cross-referencing requirements, and keeping track of what you found along the way.

Today, most of that work happens on a screen, often with multiple documents open side by side. While we have moved from paper to screens, the difficulty of doing a thorough review has not really changed.

The challenge is still the same: finding what’s missing, what doesn’t line up, what’s outdated, and what could create a compliance risk.

That’s the gap 𝐕𝐄𝐑𝐀 was built to close.

Ready to see how VERA handles the heavy lifting? Comments "VERA" to book a live demo.

09/30/2026

In MedTech, we’re used to validating complex technologies. But when AI supports our processes, validation alone isn’t enough.

AI can evolve, models can be updated, and its use can shift over time. That means we need ongoing monitoring and governance to ensure it continues to perform reliably, consistently, and as intended.

Trust in AI isn’t a one-time checkbox. It’s an ongoing process.

Watch Becky Legare break down why this distinction matters for AI governance.

09/29/2026

We demoed VERA live at MassMEDIC’s Regulatory, Payment and Policy Conference to a room of MedTech leaders.

Here’s BSI’s reaction when they watched it run. 👀

Want to see how VERA holds up against your own quality system? Link in the comments to book a live demo, or send us a DM or comment to book a live demo.

09/25/2026

Everyone knows their QMS could be better.

Over time, small fixes and acquisitions with partially integrated systems can cause procedures and processes to stop aligning. Gaps, inconsistencies, and broken links begin to accumulate, but finding the time and resources for a full QMS assessment and remediation feels impossible.

𝐓𝐡𝐚𝐭’𝐬 𝐰𝐡𝐲 𝐰𝐞 𝐛𝐮𝐢𝐥𝐭 𝐕𝐄𝐑𝐀.

Warwick’s VERA™ QMS Assurance Platform reviews your entire Quality Management System; analyzing procedures, policies, and work instructions for continuity, conflicts, inconsistencies, and gaps against U.S. regulatory requirements and international standards.

The best part? It does it in under an hour. ⏱️

VERA does the heavy lifting. Your experts 𝐭𝐫𝐮𝐬𝐭, 𝐛𝐮𝐭 𝐯𝐞𝐫𝐢𝐟𝐲.

Ready to see VERA in action? Hit the link in the comments to book your demo.

09/24/2026

"𝐈𝐭’𝐬 𝐧𝐨𝐭 𝐚 𝐦𝐚𝐭𝐭𝐞𝐫 𝐨𝐟 𝐢𝐟 𝐰𝐞’𝐫𝐞 𝐠𝐨𝐢𝐧𝐠 𝐭𝐨 𝐮𝐬𝐞 𝐀𝐈, 𝐢𝐭’𝐬 𝐚 𝐦𝐚𝐭𝐭𝐞𝐫 𝐨𝐟 𝐰𝐡𝐞𝐧 𝐚𝐧𝐝 𝐦𝐨𝐫𝐞 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭𝐥𝐲, 𝐰𝐡𝐞𝐫𝐞 𝐚𝐧𝐝 𝐡𝐨𝐰."

This month, Warwick Consulting’s VP of Quality, Regulatory & Clinical, Becky Legare, joined BSI as a Keynote Panelist at MassMEDIC’s Regulatory, Payment & Policy Conference to discuss the growing role of trustworthy AI in MedTech.

At Warwick, we believe AI should augment human expertise, not replace it. The right QMS Assurance AI tool can do the heavy lifting by:
🔹 Uncovering compliance gaps
🔹 Accelerating complex document reviews
🔹 Allowing your experts to focus on critical risk and decision-making

How is your team preparing for the AI shift? Let us know below! 👇

If you are ready to build a compliant AI strategy, let's get specific. Send us a DM to connect with our consulting team today.

09/17/2026

Last week at the MassMEDIC Regulatory Policy and Payment Event, we co-hosted a Keynote Panel with BSI to explore one of the hottest concerns in MedTech right now:

What is the biggest barrier to trusting and using AI in a regulated industry?

The response that resonated most with attendees was:
“Knowing that AI will perform reliably, consistently and as intended over time.”

That response gets to the heart of the conversation around trustworthy AI: It's not just about what AI can do today, but how we build confidence that it will continue to perform as intended over time.

Another key takeaway from our discussion was that regulatory agencies are already using AI. As an industry, we have an opportunity to think more strategically about how we deploy AI to become better informed, make better decisions, and work more efficiently while maintaining the human judgment and oversight needed to use AI responsibly.

More highlights from the event coming in the days ahead.

09/09/2026

Boston. September 9th. Doors are open and the room is filling up.

BSI and Warwick Consulting take the stage this afternoon to talk AI trust at MassMEDIC's Regulatory, Payment & Policy Conference.

Come find us if you're here today. 🤝

09/08/2026

Tomorrow.

BSI and Warwick Consulting take the stage at MassMedic's Regulatory, Payment & Policy Conference in Boston for a session on trusting AI in the regulated MedTech industry.

If you are attending, come find us, we would love to connect and hear your thoughts. If you cannot make it, we will share key moments from the event here.

Looking forward to seeing you at the event!

Address

145 Longwood Avenue #2
Brookline, MA
02446

Telephone

+16175134121

Website

https://warwick.consulting/

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