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

Steve Gompertz is a leader in Quality Systems management.  His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data.  He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, project management, and configuration management.

Mr. Gompertz has developed a Quality Systems Capability Model merging Risk Management and CMMI concepts to create the only method available to quantitatively measure a quality system's effectiveness and potential.  He is also responsible for coining the term, "dysfunctional compliance" to describe the situation where a company meets all regulatory and statutory requirements but still experiences significant quality issues due to not addressing quality from a true systems perspective.

StrengthsFinder Results:
     Ideation, Strategic, Significance, Maximizer, Relator

Specialties: Quality Systems Design, Audit, & Capability Assessment
Process Improvement
Project Management
Procedure & Forms Development
Quality Systems Guidance and Training
Product Data Management (PDM) Systems Implementation
Mechanical Design Automation

taplio

The Battle

Karandeep Badwal

Steve Gompertz

Followers

Posts

Engagements

Likes

Ready to grow your LinkedIn presence?