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

Galen Data

Responsible for general operations of medical device software (SaaS) company creating and operating a configurable and scalable software platform that makes it "easy" to connect medical devices to a FDA compliant cloud.

Tietronix Medical

Primary person responsible for designing, adapting, and marketing custom software services and products for the medical device industry.  Current concentration is providing technical and managerial leadership for a Food and Drug Administration (FDA) design control software automation project.

Initiated and drove the effort to create a new Life Science Division within Tietronix, with a focus on pursuing commercial medical device software development services and commercialization of an internally developed web-based Quality Management System (QMS) for the medical device industry.

Provided critical technical expertise and leadership while driving the development of a web-based workflow QMS product called MDA, targeted at small to mid-size medical device companies.  The product provides an enterprise level suite of process (medical device design controls) and tools (Document Controls, Review Boards, CAPA, Training, Non-Conformance, Project Management, Audit Trails, etc) that are required to run and operate a medical device company in a cost efficient manner.

Initiated and led the effort to achieve ISO certification.  This included building from scratch a compliant ISO 13485 (Medical Device – Quality Management System International Standard) system (ISO procedures) designed to work with the QMS product MDA.

Director of Product and Business Development

Medical Device Consultant

Providing medical device services to established and early stage medical device companies.
--Software Development (IEC 62304)
--Design Controls (CFR 820.30)
--Regulatory Reviews (PMA, PMAS, Real-Time, 510(k))
--Verification and Validation (IEC 60601-1-4, EN45502-1)
--Quality Management Systems (ISO 13485)
--Product Life Cycle (project plans, requirements capture, design documentation)  
--Hazard and Risk Analysis
--Document Control (configuration management) 
--Project Management

EverHeart Systems Inc.  (Early Stage Medical Device)

Sole Director in early stage and well funded ($11 m) Class III cardiac medical device
company. Perform various roles critical to a startup medical device company including software development, quality assurance, contractor oversight, authoring and contributing to project plans, writing technical specifications, developing ISO 13485 operational procedures, and conducting technical design efforts.

Specific duties include:
Designing and developing a fully working first-phase Physician Programmer touch screen tablet software application written in C# using the MICS (Zarlink implementation) wireless communication band to command and control the electronic prototype board.

Designing and developing a data acquisition C# application that acquires analog and digital signals using COTS (commercial off the shelf) modules to log, calculate RMS values, and graph in real-time power and speed parameters from the electronic prototype board.

Selecting and assembling components for an external controller to operate and record rate, power, and alarm conditions of an external device using COTS hardware. Developing supporting software application in C# that directly interface via serial RS 485 communication with the external controller to visually graph, trend, and log parameter data.

Creating prototype requirements and verification matrix for animal study electronic hardware (microcontroller based) and aiding in technical evaluation of completed prototype. Supporting first animal implant, two week study of prototype hardware at a GLP (Good Laboratory Practices) research facility.

Implementing and configuring electronic document review and approval process using a commercial ISO 13485 management and documentation tool.

Authoring, contributing to, and reviewing formal Operational Procedures, Hazard Analysis, User System Requirements, Hardware Requirements, and Software Requirements documents.

Co-inventor on “Mobile Wireless Power System” patent filed March 15th, 2013.

Director (Multiple Roles)

LivaNova

Project Manager and principal Software Engineer responsible for executing key software projects through a formal design control and validation acceptance phase for the FDA review process for Class III Medical Devices.  Principal investigator for new software applications, enhancements, and platforms for use with Cyberonics VNS (Vagus Nerve Stimulator) Programming Software and Implantable Pulse Generator.

Project Manager and Technical Lead for first ever FDA approved (Class III Medical Device) programmer software application deployed on a COTs (Commercial Off the Self) handheld computer (Pocket PC 2002/2003 [Windows CE]) at a cost saving to the corporation of over one million dollars annually.

Supported the growth of the company from zero commercial sales to over $120 million in sales.  This included managing processes through a 10-fold increase in employees - from 70 employees in the beginning, to over 700 employees several years later.  Processes included multiple new therapy indication submissions, regulatory reviews (PMAs and Real-Time Reviews), product releases, and significant FDA Class III activity.

Filed five medical device patent applications with two being issued to date.

(Cyberonics became LivaNova)

Project Manager/Lead (Software Engineer)

CEO and Co-founder of Galen Data, a medical device software company. 

Galen Data’s turn-key, FDA compliant platform solution provides device-to-cloud connectivity and data collection, storage and analytic//visualization tools -- enabling medical device makers to reduce costs and time to market.

In this role, Chris formed the relationship between Tietronix (incubator) and raised seed and bridge funding for initial product development and marketing. Chris co-authored Galen’s patent application “Systems and Methods to Automate Transfer, Storage, and Analysis of Medical Device Data."

Core Expertise: 

FDA Class III Medical Device Software
Medical device quality management implementation - ISO 13485:2016 certification
- IEC 62304, ISO 14971
Early stage medical device companies
Product development lifecycle  - from concept, to development, to deployment

For more information, visit www.galendata.com


taplio

The Battle

Karandeep Badwal

Chris DuPont

Followers

Posts

Engagements

Likes

Ready to grow your LinkedIn presence?