KN Consulting and Services

Global regulatory and quality consulting for medical devices and IVD

11-50 employees

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About KN Consulting and Services

KN Consulting and Services is a regulatory affairs and quality assurance consultancy specializing in medical devices and in vitro diagnostics (IVD). The firm provides comprehensive support for navigating global regulatory frameworks including US FDA, EU MDR/IVDR, Health Canada, and ISO 13485:2016 compliance. With over 20 global clients served, the company works with both established medical device manufacturers and emerging healthcare technology companies.

The firm's service portfolio spans the full product lifecycle, from pre-market regulatory submissions (510(k), De Novo, PMA, CE marking) through post-market surveillance and quality system maintenance. Their team has demonstrated expertise in preparing Health Canada Medical Device Licence (MDL) applications, EU technical files, and FDA submissions, with client testimonials noting successful submissions with minimal regulatory questions. KN Consulting also offers offshore staffing solutions for companies seeking to build dedicated quality assurance and regulatory compliance teams.

The company has worked with notable organizations including Siemens Healthineers, Terumo Medical Corporation, and Alma Lasers, supporting projects ranging from IVDR compliance to complex master memorandum creation. Their approach emphasizes bespoke solutions, tight timeline adherence, and comprehensive documentation support.

Best For

KN Consulting is best suited for medical device and IVD manufacturers seeking regulatory approval in multiple markets simultaneously, particularly those targeting US, European, and Canadian markets. The firm is well-positioned to support mid-sized medical device companies and healthcare technology startups that need expert regulatory guidance but may not have in-house regulatory affairs departments. Companies facing complex classification questions, EU MDR/IVDR transitions, or tight submission deadlines will find their specialized expertise valuable.

Key Strengths

Proven track record with major medical device manufacturers including Siemens Healthineers and Terumo Medical Corporation, demonstrating capability to handle complex, high-stakes regulatory projects
Multi-market regulatory expertise covering FDA, EU MDR/IVDR, Health Canada, UKCA, and other international frameworks from a single provider
Strong performance on Health Canada submissions with client testimony of minimal regulatory questions and successful dual submissions within tight timeframes
ISO 13485:2016 quality management system expertise with detailed understanding of the 2016 standard evolution and implementation requirements
Offshore team augmentation services providing cost-effective access to regulatory and quality professionals for extended engagements
Comprehensive lifecycle support from design history file development through post-market surveillance and complaint handling

Why Choose KN Consulting and Services

Choose KN Consulting when you need a regulatory partner with demonstrated success navigating complex multi-market approval processes for medical devices and IVD products. Their experience with both traditional Class II/III devices and emerging IVD technologies under IVDR makes them particularly valuable for manufacturers facing the evolving European regulatory landscape. The firm's ability to manage parallel submissions across multiple jurisdictions can significantly accelerate time-to-market for companies with global expansion plans.

Expect a structured, organized approach with regular touchpoints and comprehensive documentation support. Their offshore staffing model also provides flexibility for companies needing extended regulatory or quality resources without the commitment of full-time hires. The firm appears to excel in situations requiring meticulous documentation, tight deadline management, and thorough understanding of harmonized standards like ISO 13485:2016.

Healthcare Focus

KN Consulting operates exclusively within the medical device and IVD sectors of healthcare, with 100% focus on regulatory compliance and quality assurance for these product categories. Their healthcare expertise centers on navigating the complex regulatory pathways required to bring medical technologies to market while maintaining ongoing compliance with quality standards like ISO 13485:2016 and jurisdiction-specific regulations.

The firm demonstrates deep understanding of healthcare-specific requirements including risk management (ISO 14971), clinical evaluation, post-market surveillance, and medical device unique device identification (UDI). Their work spans multiple healthcare verticals including diagnostic equipment, surgical instruments, patient monitoring devices, and therapeutic technologies, with client examples ranging from laser systems to cardiovascular devices.

Ideal Client Profile

Medical device manufacturers and IVD companies in Class II and Class III categories seeking regulatory clearance in US, European, or Canadian markets. Companies undergoing EU MDR/IVDR transitions or those without established in-house regulatory affairs teams. Mid-sized manufacturers (10-500 employees) needing flexible regulatory support ranging from specific submission projects to ongoing quality system management. Startups preparing for first commercial approvals who need comprehensive regulatory strategy and execution support.

Specializations

FDA 510(k) submissions EU MDR/IVDR compliance ISO 13485:2016 implementation Health Canada medical device licensing Medical device quality management systems IVD regulatory consulting MDSAP auditing