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

Pace® Life Sciences

QA Specialist

Cenmed Enterprises

Lead the strategic planning, development, and execution of a comprehensive enterprise Quality Management System (QMS), ensuring full alignment with regulatory requirements and industry standards.

Champion the implementation of quality policies, methodologies, and business processes across all organizational functions, driving a culture of compliance, continuous improvement, and operational excellence.

Collaborate with cross-functional teams to embed quality principles into daily operations, ensuring consistent adherence to best practices and the proactive identification of opportunities for process optimization and risk mitigation.

Implemented detailed process mapping for product, assembly development and QMS workflows, clearly defining roles, responsibilities, and control points to maintain regulatory compliance and enhance audit readiness.

Develop and implement comprehensive regulatory strategies that encompass ISO 14001, ISO 27001, ISO 45001, and ISO 17025 standards.

Quality and Sustainability Manager

Drive a culture of continuous improvement by identifying opportunities for enhancement and implementing initiatives that align with quality objectives and organizational goals.

Provide guidance and proactively ensure compliance with all applicable internal, domestic, and international quality regulations, including US 21 CFR 820 (QSR), EU MDR, ISO 13485, and 14971.

Evaluate functional strengths and developmental areas in the QMS, focusing on continuous improvement and organizational agility.

Spearhead sustainable product development initiatives, incorporating cutting-edge materials research and compliance with industry standards such as ASTM F1670, F1671, and F903.

Conduct ESG assessments and analytics, including emissions calculations (e.g., GHG), data collection, due diligence questionnaires, progress tracking, and reporting.

Establish and maintain ESG reporting and communication strategies, serving as the primary contact for ESG-related inquiries from customers and vendors.

Quality and Sustainability Analyst

Prime Wholesalers LLC

Boutique Biodegradable Plastics Manufacturing
Hydroponic Fertilizer Formulation and Sale

Prime Wholesalers sources high quality pet and plant goods and passes the savings on to you!

Check us out on Instagram @Prime.Wholesalers

Founder

DIYA CARE INC

Ensure the coordination of claim activities and designated agencies, and the timely reimbursement of receivables.

Identify any issues or trends and bring them to the attention of management.

Research, resolve, and prepare claims that have not passed the payer edits daily. Determine and initiate action to resolve rejected invoices.

Assures re-billings and/or adjustments are processed appropriately and timely.

Clear payment variances, resolving differences, and initiating corrective action.

Accounts Receivable Manager

RUCDR Infinite Biologics

Led site-wide Computer System Validation (CSV) to ensure compliance with FDA Title 21 CFR Part 11 and GxP requirements.

Familiar with FDA GxPs, 21 CFR Parts 11, 58, 210, 211, 600, 606, 801, 803, 820, 1270, and 1271, CLIA, CAP, HIPAA, EMA, MHRA, ICH, Eudralex, PIC/s, and WHO.

Assessed Analytical Equipment (AE) and automated robotics against GxP, data integrity, and Part 11 compliance.

Proficient in GAMP 5 risk-based methodology and V model artifacts, including URS/FRS/DS, RTMs, IQ/OQ/PQ Protocols, and Validation Summary Reports.

Assisted in method validation and SAT for PE Cell Explorer G3 Workstation.

Analyzed CSV and VMP SOPs for compliance with Part 11 and SDLC best practices.

Trained and mentored co-workers in Spreadsheet Validation, Part 11, and GAMP 5 methodology.

QA Laboratory Technician

Min Patel Consulting

Managed small retail client accounts by providing IT and business solutions to solve needs and exceed expectations

Evaluated, designed and implemented advertising and marketing plans to expand client reach while increasing profits

Assessed and expanded Point of Sale (POS) system, generated gross inventory value metrics to provide strategic insights

Reviewed and resolved formula errors on various business operation spreadsheets, prevented legal and financial repercussions

IT Business Consultant

IT View, Inc

Client: LA Care

Created and completed over 900 detailed test cases for Agile File Transfer Protocol (FTP) and Key Performance Indicator (KPI) Report projects, recommended by IT manager for contract to full time conversion after only 2 months

Tested Extract, Transform and Load (ETL) test cases for Enterprise Data Warehouse (EDW) project, resulted in increased experience of business rules, strategies and data mart concepts

Managed multiple projects simultaneously as the only QA resource, prepared test plans and provided daily/weekly status reports, resulted in heightened communication, time management and leadership skills

Conceptualized and executed SQL queries in Oracle, assured back end database and flat file data integrity

QA Engineer

Synchronisys, Inc

Client: Associated Bank

Documented, analyzed and resolved over 300 valid defects using HP QC/ALM 11 when testing Loan Origination System (LOS) Re-Implementation project, identified the most bugs on the team by over 100 deviations in 3 months

Developed and executed over 500 test cases related to Interfaces (CBC/Innovative Credit, Desktop Underwriter (DU), Early Check, FEMA Flood, Interthinx FraudGuard and PredProtect), Loan Eligibility, Change Controls, Hot Fix Items, Disclosure Documents, Home Mortgage Disclosure Act (HMDA) Reporting, Adaptive Configuration Efficiency (ACE) Action Items, Secondary Pricing Adjustments, Special Feature Codes, Audit Logs, Authorized User Access and Security, Web Portals, Field Auditing, Custom System Tasking and Business Workflows for configured Commercial Off the Shelf (COTS) Accenture Mortgage Cadence (AMC) – Enterprise Lending Center (ELC) system, streamlined ticket resolution by 15 percent and complimented by managers for comprehensive defect reports

Performed User Acceptance Testing (UAT), End to End (E2E), Regression, Smoke, Ad-hoc, Usability and System Integration Testing (SIT) for ELC, resulted in versatile and thorough test strategy skills

Supported the Know Before You Owe (KBYO) and Know Your Customer (KYC) projects remotely using Citrix Receiver with minimal supervision, originated over 700 loans and trained coworkers by initiating knowledge transfers (KT) in person and through WebEx and GoToMeeting

QA Analyst

Quality Engineer (QE) with over a decade of expertise in testing databases, web-based, and client/server applications while ensuring compliance with Quality Management System (QMS) standards including ISO 9001, ISO 13485, and 21 CFR 820 Quality System Regulation (QSR).

Proficient in Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC), Business Intelligence (BI), and Computer System Validation (CSV) and Assurance (CSA). Understanding of Corporate Social Responsibility (CSR) and Environmental, Social, and Governance (ESG) strategies.

Proven track record in highly regulated industries such as lending, healthcare, and life sciences, driving continuous improvement and operational excellence.

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