EU MDR and General Regulatory Strategy
- Regulatory pathway planning
- Medical-device qualification and classification support
- Identification of applicable EU MDR requirements
- Regulatory gap assessments
- Support planning conformity assessment activities
Medical Device Regulatory Consulting
Medical Device Regulatory Consulting
Practical, expert-led support for medical device and digital health companies navigating EU regulatory requirements, CE-marking preparation, ISO 13485 Quality Management System and European market entry. Led by Dr Mart Veerus.
Book a consultationConsultations in this service are booked directly with Dr Mart Veerus, Co-Owner and Lead for MDR Consulting.
CE Marking Preparation
- CE marking readiness assessment
- Support structuring regulatory and technical documentation
- Identification of evidence and documentation gaps
- Coordination support when working with external Notified Bodies and specialist partners
Quality Management System and ISO 13485
- QMS development and improvement support
- ISO 13485 related consulting
- Internal audit preparation and support
- Process mapping and documentation
- Quality and regulatory gap assessment
- Audit readiness support
PRRC and Ongoing Compliance Support
- Guidance concerning PRRC responsibilities
- Support establishing regulatory compliance processes
- Post-market surveillance and vigilance process support
- Ongoing regulatory and quality advisory
Digital Health and Medical Device Software
- Regulatory support for digital health products
- Medical device software and digital medical applications
- Regulatory strategy during product development
- Support connecting clinical, product, quality and regulatory requirements
European Market Entry
- EU market entry planning
- Guidance concerning the roles of Authorized Representatives, importers, distributors, competent authorities, PRRCs and Notified Bodies
- Documentation readiness support
- Coordination with independent Authorized Representatives and other regulatory partners
The scope of our role
- We provide consulting, guidance, preparation and readiness support. KSN Advisory does not grant, guarantee or independently approve CE marking, and is not a Notified Body, certification body or competent authority.
- KSN Advisory provides guidance and coordination concerning Authorized Representatives, but does not currently act as an EU Authorized Representative and does not accept Authorized Representative mandates.
- We support QMS development and ISO 13485 related activities as consultants; we are not an ISO certification body.
- Formally serving as a client's PRRC is not part of these services unless separately agreed and legally assessed for that specific engagement.
Pricing
Pricing depends on the scope of the engagement. Send an email or book a consultation and you'll receive an exact quotation before any work begins.
Book a consultationConsultations in this service are booked directly with Dr Mart Veerus, Co-Owner and Lead for MDR Consulting.