MB&A

We provide consulting and recruiting services for medical device manufacturing companies. Ask us how!

04/28/2026

💡 Save $100 on your OMTEC 2026 Registration.

Great partnerships drive great products. As we gear up for OMTEC 2026, we want to ensure our network — from startups to global OEMs — is well-represented in Chicago.

Whether you're looking to scale your QMS, prepare for your next FDA inspection, or navigate the complexities of supplier risk, OMTEC is where the industry solves its hardest problems.

Register today using the MB&A partner code OMTECROCKS to instantly save $100 on your pass.

We'll be at Booth #710 all three days. Stop by and let's talk about what 25 years of MedTech quality and regulatory expertise can do for your operations.

Register here: https://zurl.co/2RBf1
Code: OMTECROCKS

&A

03/31/2026

End of quarter is often when the pressure shows up.

Open audit findings.
Delayed submissions.
PMS gaps that suddenly feel urgent.

This is where MB&A partners with MedTech teams, not just to fix what’s broken, but to build systems that reduce friction quarter after quarter. From Quality and Regulatory to audits, remediation, and post-market strategy, our work is about making compliance sustainable, not reactive.

If this quarter surfaced challenges you don’t want to repeat, let’s talk before the next one starts.

Explore our services or start a conversation.

https://www.burtandassociates.com/all-services

03/17/2026

In MedTech, compliance isn’t about luck. 🍀

And audits definitely aren’t something you want to leave to chance.

Strong quality systems, clear processes, and early risk visibility beat four-leaf clovers every time. The teams that feel “lucky” during inspections are usually the ones who prepared long before the auditor arrived.

This St. Patrick’s Day, we’re raising a glass to preparation, not superstition.

If audits feel unpredictable, let’s talk about how to change that.

https://www.burtandassociates.com/

03/13/2026

What if audits weren’t just something you survived?

The problem isn’t that quality teams aren’t working hard enough.
It’s that the audit model itself is outdated, reactive, subjective, and impossible to scale.

In our white paper, we explore how audits became a compliance tax instead of a source of insight, and how forward-looking teams are reframing audits as a driver of clarity, consistency, and control.

This isn’t about doing more audits.
It’s about getting more value from the ones you run.

Access the full paper to see what’s changing, and why it matters now.

Read the full white paper: https://www.calameo.com/read/00674077120c14ce56b59

03/10/2026

Behind every strong quality system is someone who understands both the regulation and the reality.

Amber Lenz brings deep experience across Quality and Regulatory functions, helping MedTech teams untangle complex requirements and build systems that actually hold up under inspection.

Clients trust Amber not just for her technical expertise, but for her ability to translate expectations into practical, defensible action.

We’re proud to have her on the MB&A team.

Learn more about Amber and her work at MB&A.

https://www.burtandassociates.com/amber-lenz-bio

03/06/2026

Compliance doesn’t stand still, and neither should your insight.

Beyond Compliance is our LinkedIn newsletter for MedTech leaders who want timely regulatory updates, practical audit prep guidance, and perspective on where quality expectations are headed next.

No noise. No recycled headlines. Just clear insight from people who live this work every day.

📰 Subscribe and stay ahead of what’s changing.

https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7333911061001129985

03/03/2026

Post-Market Surveillance has changed, and regulators are paying closer attention.

With EUDAMED live and PSURs becoming more visible, PMS is no longer a periodic reporting exercise. It’s a continuous signal of compliance maturity. Regulators are comparing PSURs against complaints, vigilance data, and UDI records, and inconsistencies are easier than ever to spot.

If your PMS processes were built for the old model, the risk is growing.

We’ll be sharing more soon on what strong, regulator-ready PMS actually looks like under EU MDR, and what teams should be doing now to prepare.

Stay tuned for deeper insights.

02/24/2026

Audits were supposed to create confidence.

For too many MedTech teams, they do the opposite.

Manual audits built on spreadsheets, checklists, and subjective interpretation create the illusion of control, while real risk hides in the gaps. Inconsistent outcomes. Missed signals. Teams stuck reacting instead of leading.

Our latest white paper breaks down why the traditional audit model is no longer fit for today’s regulatory and supply chain realities, and what quality leaders must do next.

📄 Read the white paper and rethink what audits should actually deliver: https://www.calameo.com/read/00674077120c14ce56b59

Have questions? Drop them in the comments below!

02/17/2026

We help MedTech companies move forward with clarity and confidence. Everything we do is grounded in one goal: building systems that work in the real world, not just on paper.

Learn more about how we support MedTech teams at burtandassociates.com.

02/06/2026

Reid Hoffman’s Superagency isn’t written for MedTech, but the parallels are hard to ignore. For QA/RA leaders, responsible AI adoption can translate into very practical gains:

• Faster harmonization across SOPs and technical files
• More efficient, insight-driven audit preparation
• Deeper visibility into supplier risk
• Smarter post market signal detection
• Capacity relief for lean quality teams

This isn’t about replacing people. It’s about giving experienced professionals better tools.

Which of these would make the biggest difference for your team right now? Comment below.

Address

2156 Johnson Road
Germantown, TN
38139

Website

http://www.burtandassociates.com/

Alerts

Be the first to know and let us send you an email when MB&A posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Business

Send a message to MB&A:

Shortcuts

Want your business to be the top-listed Business in Germantown?