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

SIMPLIFY, business consulting, Matija Rupnik s.p.

I am pleased to present my company, which offers a comprehensive range of business and regulatory consulting as well as educational services in the field of medical devices. With years of experience and a deep understanding of the industry, I am dedicated to helping clients navigate the complex landscape of medical device regulations and optimize their business operations.
If you are seeking expert guidance and support, I invite you to connect with me to discuss how I can assist you in achieving your business and regulatory goals.

Owner

Cosylab

- Regulatory and Quality Assurance support on medical projects
- Regulatory Due Diligence
- Preparation and execution of regulatory strategies for medical devices
- Consultation of marketing strategies for medical devices
- Identification of applicable regulations and standards for medical devices in targeted markets
- Identification of applicable regulatory requirements and standards for medical devices in regard of its type and classification
- Coordination of activities related to certification and registration of medical devices
- Person Responsible for Regulatory Compliance - PRRC (Art. 15 of EU MDR 745/2017)
- Communication with Notified bodies and Regulatory Authorities
- Introduction of new system regulations
- Maintenance of QMS compliance with the requirements of applicable quality management standards
- Maintenance of standards database
- Implementation of requirements of new editions of standards
- Maintenance of QMS Certificates
- Coordination of activities related to external audits and inspections
- Organization and execution of internal audits
- Resolution of non-conformance and implementation of corrective actions
- Determination of project and product life-cycle QA gates
- Implementation of quality measurements
- Validation of QA controlled tools
- Performing internal trainings and lectures in the field of quality

Regulatory Affairs Manager

SIQ Ljubljana

- External expert associate for Slovenian Institute of Quality and Metrology - SIQ
- Registered auditor for ISO 9001:2015, ISO 13485:2016 and MDR 2017/745
- Lecturer in the field of medical devices

External expert associate

ArrowFast Medical Device Engineering

ArrowFast is a trade mark of Cosylab Switzerland. As a medical device software specialist, we help MedTech startups get to their next milestone. Our in-house team of 220 engineers helps medical device startups from planning to developing their device and making sure it's certified for the targeted market. We make sure it is done at a fixed budget, and that a startup can stay lean and agile.

Iskra Mehanizmi, d.o.o.

▪	Care for system (QMS) compliance with the requirements of standards, legislations and customers
▪	Coordination of external audits and inspections from customers and international organizations
▪	Leadership of system projects for implementation of requirements of FDA CFR 21 part 820, EN ISO 13485:2016 and EU MDR 745/2017 into quality management system of the company
▪	Monitoring, coordination and implementation of customer requirements
▪	Supporting customers at certification of medical devices on US and EU market
▪	Communication with Notified bodies and FDA
▪	Certification of new company location according to EN ISO 13458:2016
▪	Participation in risk management of system processes according to EN ISO 14971:2012
▪	Performing internal trainings in the field of quality
▪	Introduction of new system regulations
▪	Internal instructor for field of medical devices
▪	Performing internal audits (ISO 9001:2015, EN ISO 13485:2016, IATF 16949:2016, VDA 6.3, FDA CFR 21 part 820)

System quality engineer

▪	Care for system (QMS) compliance with the requirements of standards, legislations and customers
▪	Monitoring, coordination and implementation of customer requirements
▪	Participation in external audits and inspections from customers and international organizations
▪	Performing internal trainings in the field of quality
▪	Work in SAP QM-module
▪	Leadership of system projects for implementation of requirements of FDA CFR 21 part 820 and EN ISO 13485:2016 into quality management system of the company
▪	Introduction of new system regulations
▪	Participation in projects for Smart factory (Industry 4.0)
▪	Participation in process validation 
▪	Performing internal audits (ISO 9001:2015, EN ISO 13485:2016, IATF 16949:2016, VDA 6.3, FDA CFR 21 part 820)
▪	Creation of APQP documentation (MSA, SPC, FMEA, CP, PPAP)

Quality Planning Engineer

▪	Arrangement and supervision of work and responsibility for the work of the Q-planning team
▪	Reporting to quality manager
▪	Assistance in managing of the quality department
▪	Identification and implementation of customer specific requirements
▪	Performing trainings in the field of quality
▪	Work in SAP QM-module
▪	Care for system (QMS) compliance with the requirements of standards, legislation and customers (electro, automotive and medical industry)
▪	Participation in external audits from customers and international organizations
▪	Supervision of the internal audit process
▪	Running actions to raise the quality level through the company, the supply chain
▪	Solving complex problems and conflict situations
▪	Performing personal interviews
▪	Leadership of system projects

Head Of Quality Planning Department

▪	Monitoring and coordination of customer requirements
▪	Communication with customers
▪	Creation of APQP documentation 
▪	Creation of control plans
▪	Moderating FMEA analysis
▪	Performing MSA analysis of measurement and control equipment
▪	Performing SPC analysis
▪	Creation of PPAP documentation
▪	Work in SAP QM-module
▪	Performing internal audits 
▪	Troubleshooting of non-compliances – complaints (8D) and non-conforming products
▪	Participating in prototype testing
▪	Care for 5S

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