Getting your medical device approved shouldn’t take years of trial and error

I help early-stage MedTech founders get a clear EU MDR, UKCA and/or FDA regulatory strategy in just 30 days so they can move forward with confidence, reduce delays and get to market faster

The problem:
Many founders are unsure which pathway applies, what documents are required or how to avoid months of regulatory back-and-forth. Without a clear plan, they risk burning runway, missing opportunities and losing investor confidence

How I help:

- Map the exact regulatory pathway (CE, UKCA, 510(k), De Novo, PMA)
- Define intended use & classification to align with regulators
- Build a step-by-step submission readiness plan
- Provide hands-on support for technical documentation, QMS & audits
- Guide devices including SaMD, AI/ML, hardware and IVDs through IEC 62304, IEC 82304, applicable ISO standards and emerging AI frameworks

Full capabilities:

Regulatory consulting: CE marking under MDR/IVDR, UKCA certification, FDA pathways (510(k), De Novo, PMA). PRRC & UKRP services. Gap assessments, submission support & strategic planning

Quality assurance: Implement & remediate QMS to ISO 13485 & MDSAP. Lead audits, manage CAPAs & complaints, support risk management (ISO 14971), process validation (IQ, OQ, PQ) & sterilisation (ISO 11607). Certified ISO 13485 Lead Auditor (CQI/IRCA)

Digital health / SaMD: Compliance with IEC 62304, IEC 82304 & AI/ML frameworks. Software validation & CSV for regulatory alignment

eQMS platforms: Implement Greenlight Guru, Qualio, MasterControl, JIRA & Confluence, with CSV to ensure audit readiness

Due diligence: Regulatory & QMS assessments for investors, accelerators & M&A. Identify red flags in technical documentation & submissions before they become costly

Training & microconsulting: For teams & founders building internal capability. CQI/IRCA-registered tutor for MDR, IVDR, ISO 13485, ISO 14971 & MDSAP

I’m a startup advisor and competition judge for MedTech Innovator, Springboard Enterprises and MassChallenge. As a trainer and host of The MedTech Podcast, I work with founders, investors and accelerators worldwide to deliver regulatory clarity and practical strategies

I combine regulatory expertise with a practical, execution-focused mindset. Clients value my ability to cut through complexity, reduce time to market, pass audits and scale confidently, whether launching a first product or expanding internationally

If you’re navigating regulatory uncertainty or preparing for growth, let’s connect

🎙️ The MedTech Podcast | 📺 YouTube: @KarandeepBadwal

Karandeep Badwal

Founder & Headhunter-Med-Tech, LifeSciences & Manufacturing Industries| Industry 4.0|Automation|Podcast Host

Hiring critical talent in Med-Tech & MEP Engineering isn’t hard because there’s “no talent.”
It’s hard because the right people never see your job…
and the wrong ones flood your inbox.

Every leader I talk to is dealing with the same mess:
❌ Candidates who meet requirements but don’t move the needle
❌ Resumes that impress on paper fall apart in interviews
❌ Teams burning cycles on applicants who were never real contenders
❌ Hiring managers losing confidence in the process
❌ Timelines slipping because the right talent never even knew you existed

It’s not a sourcing problem.
It’s not a brand problem.
And it’s not a “market” problem.

It’s an access + attention problem.

Roughly 7 out of 10 qualified people are open to better roles…
but they’re not on job boards,
they’re not scrolling LinkedIn,
and they’re definitely not replying to the same recycled outreach everyone else uses.

If you want the best people,
you have to take the message TO THEM
with something worth answering.

That’s where we come in:

👉 Identify → Attract → Qualify → Deliver
Talent that makes critical impact.

Messaging built for the new age that gets candidates to take action.

The Anthony Michael Group (AMG)

Old-school headhunting with modern execution.
Regulatory. Quality. Engineering. Ops.

The roles that protect timelines, compliance, budgets, and safety.
When you can’t afford to guess… you call a headhunter.
That’s AMG.

SourceFuel™

For everything your internal team can handle
but can’t scale.

A human-driven, AI-powered sourcing engine that pierces the noise and surfaces people your team would’ve missed.

Multi-channel outreach.
Messaging that gets answered.
Qualified pipelines delivered directly to you.
No agency percentages.
No job board chaos.

You own the pipeline. We build it.

Most hiring teams don’t fail because they “can’t find talent.”
They fail because the talent they actually need never knew the role existed.

If that’s your world, especially in Regulatory, Quality, Engineering (Electrical, Mechanical, Plumbing) or Operations functions.
we should talk.


📩 mitch@theanthonymichaelgroup.com

📱 815-347-2072

Mitch Robbins

MEP engineering firms are sitting on an untapped gold mine and don’t even know it. 

It’s not AI. 
It’s not software. 
It’s not marketing. 

It’s your true Employer Value Proposition. 

The firm leaders I've spoken with lately all complain about how tough it is to recruit Sr and Mid-level engineers, but they all seem to have a hard time explaining:

• What a Senior Engineer actually owns 
• What “doing great” unlocks 
• How someone moves from Senior to Principal 
• Whether equity is real or theoretical 

Instead, the pitch sounds like: 
“Hybrid schedule.” 
“Flexible hours.” 
“Great culture.” 
“We retain our engineers.” 

That’s not an EVP. 

Senior mechanical and electrical engineers don’t leave stable jobs for flex Fridays. 

They move for trajectory. 
For influence. 
For ownership. 
For visible career momentum. 

And here’s the bigger issue… 

From the outside, most MEP firms look the same. 

Similar project types. 
Similar benefits. 
Similar language. 

So how is a strong engineer supposed to differentiate one firm from another? They can’t. 

Unless you get crystal clear on your real Employer Value Proposition. 

What do they own? 
What decisions do they influence? 
What does success unlock? 
What does the 5 to 10 year path actually look like? 

That clarity is the gold mine. 

...and the firms that can articulate it clearly are the ones that will certainly attract higher-caliber talent.

– MR

#mep #electricalengineering #mechanicalengineering

Founder & Managing Director...Connecting Critical Talent w/ Critical Roles|MEP Engineering & Med-Tech|AMG + Creator of SourceFuel™

3 things I’ve noticed in the MEP engineering talent market over the last 90 days.


#1 The senior engineer bottleneck is real

There are plenty of EITs and junior engineers coming into the field.

But firms everywhere seem to be competing for the same 7–15 year engineers who can run projects, mentor younger staff, and interact with clients.

That middle layer is where the real hiring pressure sits.

#2 Ownership paths matter more than compensation

When experienced mechanical and electrical engineers consider a move, the conversation usually shifts quickly to one question:

“What does the path to Principal actually look like?”

Many firms talk about it.
Far fewer clearly define it.

Engineers who can see that path tend to stay.
Engineers who can’t eventually start exploring.

#3 Most firms look the same from the outside

From an engineer’s perspective, a lot of MEP firms appear nearly identical:

• similar project types
• similar benefits
• similar messaging

The firms that attract the best talent are usually the ones that can clearly articulate:

• what engineers will actually own
• how they will grow
• what success unlocks over time

Clarity is definitely a competitive advantage.

Curious what others in the MEP world are seeing right now?

-MR 

#mep #mepengineering #electricalengineering #mechanicalengineering
#construction

The MEP talent shortage is about to get worse. Not better.

Most firms think this is a “tight market.”

It’s not.

It’s a structural supply problem.

Data centers are multiplying.
Healthcare projects are expanding.
Advanced manufacturing is reshoring.
Energy and infrastructure mandates aren’t slowing down.

Project demand is accelerating.

Licensed, experienced MEP engineers are not.

And here’s the uncomfortable part:

The firms that win over the next 5 years won’t be the best marketers.

They’ll be the ones who can actually staff the work.

A few roles we are working on currently:

• Associate Principal Mechanical Engineer-build the office! Salt Lake UT
• Sr Electrical Engineer- Data Centers, Denver, CO
• Junior Electrical Engineer-Healthcare, K-12, Industrial-Denver, CO
• Sr Commissioning Engineer-Tri-state travel (CO, ID, UT)

Colorado. Utah. Growing markets.

If you’re an engineer sitting on a backlog of redlines with no real upside, this is your window for leverage.

If you’re a firm relying on inbound applicants to solve a structural shortage, that strategy will age poorly.

Execution beats backlog. 💯 

The market is separating firms right now.

-MR

#mep #mechanicalengineering #electricalengineering #construction #datacenters

Are you open to exploring Bay area Med-Tech Quality roles? 👇 

Director/Sr Director of Quality
We have been retained by an organization that recently received PMA approval and is currently making the huge transition from R&D to Commercial. 

This role can be positioned as a Director or Sr Director of Quality with the opportunity to build your program & your staff your way.

Supplier Quality Manager:
We are also working with a series E, commercial org who is hiring a Supplier Quality Manager to help keep pace with rapid scale via partnership with a few contract manufacturers 

Sr, Staff, or Principal Design Quality Engineer:
Same org
Lots of work around next gen product line
Risk Management, Hazard Analysis, Validation protocols, etc.
***Sterilization experience for this one is a must.

Feel free to send me a DM on LinkedIn or
mitch@theanthonymichaelgroup.com

-MR

Adam Saupe
#quality #qualityassurance #medicaldevices #medtech

Regulatory & Quality pros in California… this is your window 👇


Class II Reg and ready for your gateway to class III -FDA?

We’re hiring Sr and Principal Specialists.

Want to build a Quality team in a well-funded start-up instead of playing “clean up”?
We’ve got that too.

Supplier Quality leader who’s scaled alongside a Contract Manufacturer and knows the scars that come with it?

Call us.

Design Quality Engineering pro who loves a clean verification protocol but hates when someone says “we’ll just document it later”?

Send me a DM.

Only thing I’m kidding about is the channel.

Call, text, email, DM.
If it’s not documented, it didn’t happen. 😎 

Just don’t wait.

Happy Friday,
MR

#regulatoryaffairs #quality #medicaldevices #medtech

Adam Saupe made one of the toughest placements in US MEP Engineering in just under 2.5 weeks this week. Here's how it went down:

What:
50+ yr old MEP firm had been searching for an Electrical Engineer for quite some time.

Someone they could groom for a future ownership slot

Someone who came with experience in the verticals they serve (healthcare, k-12)

How:
Adam, with the help of our research team, quickly mapped the local Denver MEP Electrical Engineering market to identify those who had the relevant experience.

He created a multi-channel outbound recruitment campaign including creative channels like video to text, linkedin selfie videos

He found a candidate who had all the right motivations to make a change, the eagerness to prove himself & enough experience to give confidence to what he could do in the future with a new employer.

Client knew what they wanted. Candidate knew what they had to offer him (career upside, mentorship, project diversity, technology).

Adam drove the urgency behind the process realizing how in-demand this skillset is to the market at-large.

Offer made right the first time. Accepted without hesitation.

Happy client. Happy candidate.

Excellent work Adam! 

If you run an MEP Engineering firm & you are finding it difficult to attract the caliber of mid-level/Sr engineering talent you know you need, don't hesitate to reach out. 

Happy Friday,
MR

#mep #mepengineering #electricalengineering #mechanicalengineering #construction

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