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

GRAIL

To ensure regulatory compliance of GRAIL’s software products and systems and act as a subject matter expert in medical device software regulations and software development methodologies. Also to lead software design control efforts, enforce GxP and CSV principles, ensure software system audit readiness and support cross functional teams.

Senior Staff Quality Engineer

Maintained the integrity of transformative non-medical software, while leading UK Software Quality activities with software design control and enforcing GCP and CSV principles for UK Software development, crucial for pioneering products like multi-cancer early detection test.

Cisiv Ltd

. Delivery of quality and validation policies, SOPs and work instructions that are compliant to FDA and MHRA regulatory expectations and in line with industry specific standards (GAMP/ISPE)
· Worked with all relevant policies and standard operating procedures that have been defined based on the requirements of: ISO/IEC 9001:2015 Quality Management Systems and ISO/IEC 27001:2017 Information Security Management Systems
· Worked with applications developed and/or supported that can potentially contain personal data that is subject to general law (UK / EU GDPR, UK DPA 2018) as well as industry specific regulations (DSP and HIPAA).
· Provide regulatory training in CSV, GAMP5 and GCP principles to ensure regulatory compliance for relevant staff

Quality Manager

British Compliance Institute

Brought in to demonstrate the company's commitment in addressing complex compliance issues promptly and effectively, mitigating regulatory risks, and safeguarding public health.
·	Provided independent and expert assessment of the company's processes, systems, and products to identify areas of non-compliance and gaps in processes and developed a comprehensive remediation plan which included corrective actions, process improvements, training programs, and documentation updates to prevent issues from occurring in the future reducing the risk of non-compliance issues or regulatory sanctions.

Senior Validation Consultant

Experienced Quality Leader with a demonstrated history of success in diverse sectors, spanning over 9 years. Known for driving operational efficiency, ensuring regulatory compliance, and enhancing product integrity, especially in underdeveloped software environments. Skilled in implementing effective quality management systems with a strong focus on continuous improvement.

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