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

Jubilant Radiopharma

Specialist, Quality R&D

Verv Technologies

"Building an IVD 'sample to answer' blood testing platform to get biomarkers results for different tests at home to monitor the health and improve the lifestyle."

* QMS Building for internal audits
* Initiation of Design Controls
* Risk Management
* Usability/Human Factors Engineering including task analysis, workflows.
* Understand the regulations covering IVD devices.
* Supplier Management

Design Quality Coordinator 

SONOSCOPE

System Design Specialist 

Creation Technologies

IPC A 610H
SMT
PCBA Manufacturing
Through Hole Technology

Quality Control Inspector

Clarity Medical

• Carried out D&D activities for the new product development in compliance with regulatory standards ISO 13485, FDA 21 CFR 820.30, ISO 14971
• Worked for the D&D of the commercial version of Anesthesia Robot -- "Closed Loop Anesthesia Delivery System (CLADS)" in collaboration with the Department of Anesthesia & Intensive Care, PGIMER, Chandigarh, India.
• Carried out design V&V for CLADS in a simulated and clinical environment for patients undergoing cardiac and non-cardiac surgeries
• Led the product development of "Performance Utility" to analyze the data post-operatively using CLADS indicating various performance parameters with respect to various anesthetic events

Biomedical Engineer (R&D)

LHDM & Dr. Prem Hospital Pvt. Ltd.

• Management of Biomedical Department of Hospital
• Documentation of AMCs, CMCs, and PMs of medical equipment 
• Assisted service engineers in repairing and installation of various new and old medical devices
• Trained the healthcare staff in working and functioning various newly installed equipment.
• Management of ICU during COVID-19 with the team of doctors and other stakeholders
• Maintained daily logbook of issues with different equipment across different departments.
• Helped in keeping the documents updated to maintain the NABH accreditation

Biomedical Engineer

Zimmer Biomet

Recruiter: Iscientia LLC

• Worked with cross-functional teams for process improvement for existing projects in the Hips department including sub-assemblies such as Arcos, Magnum Cups
• Conducted and carried out risk management plan in compliance with ISO 14971:2019
• Conducted and assisted various IQ, OQ, and PQ protocols for new and existing equipment and processes by documenting Validation Summary Reports
• Trained team members about various new processes, GDP, SOPs, and WIs
• Led problem-solving activities by using QC tools to investigate RCA for CAPA
• Responsible for creating manufacturing routers, establishing BOM, and updating the routers to new validated operations.

Manufacturing Quality Engineer

Rang Technologies Inc

• Learned Base SAS and carried out basic coding 
• Learned the basics of SAS Clinical, enhancing the knowledge to conduct data analysis according to various SDTM domains

Data Analyst (Trainee)

LHDM & Dr. Prem Hospital

• Established Hospital’s Biomedical Department and managed the hospital’s equipment inventory and documentation.
• Assisted with service engineer in repairing critical Biomedical equipment such as Patient Monitor, Ventilator, Dialysis, and other emergency equipment resulted in gaining the knowledge of working and internal parts of different imaging equipment.
• Helped in National Accreditation Board of Hospitals and Healthcare, India (NABH) inspection of hospital.
• Evaluate the safety, efficiency, and effectiveness of biomedical equipment.
• Worked with PMs of medical equipment and dealt with AMCs and CMCs with clients and suppliers of medical equipment.

"Intention for innovation of new technologies in medical devices to provide continuous improvement for the patient outcomes!"

Experienced Biomedical Engineer with extensive experience in the medical device industry with responsibilities covering R&D, product development, manufacturing, and managing medical equipment in the hospital as a Biomedical Engineer. 

Core Competencies:
• Anesthesia Robot -- Closed Loop Anesthesia Delivery System (CLADS)
• Technical Documentation (DHF, DMR, DHR) compliant with ISO 13485, FDA 21 CFR 820, ISO 14971
• Troubleshooting, Repairing, GDP, Electrical Safety Testing, ICU, Therapeutic, and Diagnostic Equipment
• Six Sigma Yellow Belt and Lean Manufacturing including Value Stream Mapping and Kaizen
• Root Cause Analysis (Fish Bone, 5 WHYs, 7 QC Tools, CAPA)
• Design Process Control
• Process Verification and Validation (V&V)
• FMEA (DFMEA & PFMEA)
• Non-Conformance Reports (NCRs)
• Target control infusion (TCI)
• PK/PD Model of Propofol and Fentanyl
• Knowledge of anesthetic drugs such as Propofol, Fentanyl, vasopressors, vasodilators
• Data analysis using Minitab, Python, and MATLAB (Basics)
• Basic understanding of CTVS and cardiology, cardiac anesthesia
• Soft Skills: leadership, good communication skills, problem-solving, hands-on approach, quick learner

Continuous Improvement, Six Sigma, GD&T, cGMP, cGDP, Test Method Validations (TMV), DoE, FMEA (DFMEA, PFMEA), Gage R&R, Risk Management, CAPA, IQ, OQ, and PQ, MS Office (Excel, PowerPoint, Word)

taplio

The Battle

Karandeep Badwal

Himang Goyal

Followers

Posts

Engagements

Likes

Ready to grow your LinkedIn presence?