KHNORD is an independent consultancy for medical device, IVD and software as a medical device manufacturers. We help teams build quality systems that work in daily operation, prepare regulatory submissions with a clear plan, and go into audits and Notified Body reviews ready. Our work covers the United States, the European Union, MDSAP jurisdictions, Asia and Latin America.
Markets we support
- United States: FDA pathways, including 510(k), and quality system alignment
- European Union: MDR and IVDR, technical documentation and Notified Body interaction
- MDSAP jurisdictions: single-audit preparation across participating regulators
- Asia: India (CDSCO) and Japan
- Latin America: Brazil (ANVISA) and neighbouring markets
Technologies and products we work with
- Continuous monitoring devices and biosensors: glucose and other analyte monitoring, including sensor performance, clinical validation and software components
- Sports and performance wearables: heart rate and HRV based devices, and the line between wellness products and medical devices
- Software as a medical device and AI-enabled software: IEC 62304 lifecycle, ISO 14971 risk management and design history files
- In vitro diagnostics: point-of-care and rapid tests, molecular diagnostics and genomics, including prenatal screening
- Newborn screening and high-volume diagnostic kits
- Active medical devices: with embedded software and connected components
- Contract manufacturing and technology transfer: supplier oversight, transfer between sites and scale-up
What we do
- Regulatory consulting: strategy, intended use and classification, technical documentation and submissions
- Quality advisory: ISO 13485 quality systems, including electronic QMS, remediation and audit readiness
- Software lifecycle compliance: IEC 62304 processes integrated with the QMS and technical file
- Audit and inspection readiness: mock audits, gap analysis and preparation for regulator and Notified Body visits
- Insights: practical writing on regulatory and quality developments for people working in medical devices
How we work
Each engagement starts with your product, market and timeline. We work directly with your team, agree on deliverables at the start, and leave you with documents and processes your own staff can maintain. Our background spans regulatory affairs, quality and operations, so our advice accounts for what a decision means in production, supply chain and cost as well as compliance.
Who we work with
Medical device, IVD and SaMD manufacturers, from early-stage teams preparing a first submission to established companies strengthening their quality systems or entering new markets.
Led by
Kalpesh Hegde, Principal Consultant. ISO 13485 Lead Auditor and MDSAP Auditor. [Meet the consultant, linked to Professional Profile]
Work with KHNORD
