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

PBC Biomed

Regulatory & Clinical Affairs Associate

FDA 510(k) and De Novo Submissions
•	Got familiarized with  FDA 510(k) and De Novo pathways, including Pre-RFD and Pre-Sub processes.
•	Developed submission templates using the e-STAR system, ensuring FDA compliance.
EU MDR Regulations and e-Tech Submissions
•	Familiarized with EU MDR 2017/745 requirements and e-Tech file preparation for regulatory submissions.
Master’s Thesis: EU MDR 2017/745 – Challenges & Solutions
•	Completed a thesis analyzing challenges in EU MDR compliance and proposed solutions, supported by industry surveys.
Gap Assessment and SOP Improvement
•	Conducted gap assessments of internal SOPs against regulatory standards, recommending improvements.
Clinical Affairs Support – CER & SOTA
•	Conducted literature searches and updated State of the Art (SOTA) documents as part of Clinical Evaluation Reports (CER).
•	Performed similar device searches for CER compliance.

Regulatory Affairs Intern

IQVIA

● Processing of cases including narrative writing, coding patient’s medical
history and concurrent medications using MedDRA and WHO-DD.
● Working knowledge of data entry conventions and processing of safety
profiles as per ICH guidelines Vol 9A, CIOMS, FDA guidelines and New EU
legislations.
● Processed Spontaneous, market research, social media and Regulatory
authority cases from EV-Human, HA-China, Health Canada, MHRA. BfArM
and business partners.
● Hands on experience in medical devices and combination products case
processing.

Safety Associate

Wissen Infotech

•	Case Intake and Triage and Data Entry
•	Case Processing involving review, assess and processing Safety data with information.
•	Processed cases from US FDA, EV-Human, MHRA, Licensing Partner, Social Media cases.
•	Performed management of Project and fax mailbox and Case-Intake for incoming Live cases.
•	Performed Case analysis, quality check, tracking of cases (WFS activity) and reconciliation of cases as requested by managers.
•	Hands on experience interacting and acknowledging to client, business partner and other vendor company queries for immediate problem resolution and transition of activities.
•	Collaborated with managers and other senior colleagues in implementing new ideas for better work management, improving quality and productivity.
•	Selected and performed duties as SME as per project requirements.
•	Performed Mentoring for new joiners.
•	Conducted training and Quality check huddles.
•	Participated in Inspection meetings.
•	Experience on clearing Backlog cases with quality and accuracy within stipulated time.

Research Associate

Yashoda Hospitals

•	Attending patient rounds with physicians and following their treatment plan and orders in their absence.
•	Closely examining patient’s progress, physical condition and test results.
•	Counseling patients regarding disease, treatment options and proper usage of medications.
•	Conducting patient interviews, physical assessments and take medical histories
•	In case of an emergency, given required treatment to patients in absence of senior Physicians and Intensivists.
•	Maintain accurate medical records and document patient case history and treatment plan in detail.
•	Making Interventions in treatment plan by suggesting rational drug therapies.
•	Detection and reporting of drug interactions and adverse drug events while recommending appropriate alternatives and measures to solve the problem.

Physician Assistant

Malla Reddy Hospital 

•	Attended ward rounds with Senior Physicians
•	Looking out for any medication errors and reporting it to seniors.
•	Counseling patients regarding disease
•	Potential drug interactions and possible adverse drug reactions.

Pharm D Intern

Pharm D with a masters degree in Regulatory Affairs and Toxicology along with experience in Regulatory, (medical devices)  Pharmacovigilance ( Drug & medical devices)  and  Clinical domains looking out for job opportunities in Regulatory, Clinical Affairs and Drug Safety associates roles

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