Dedicated expertise in medical device regulation, built on decades of industry experience.
With over 15 years of experience in the medical device and in vitro diagnostic industries, I founded CS Medico in 2019 to provide focused regulatory consultancy to manufacturers navigating increasingly complex compliance requirements.
My career has spanned some of Denmark's most innovative medical technology companies, from global leaders to ambitious startups. This diverse experience has given me unique insight into the regulatory challenges faced by organizations of all sizes.
I believe that regulatory compliance, when approached strategically, becomes a competitive advantage rather than a burden. My approach combines deep technical knowledge with practical, results-oriented guidance that helps clients achieve their market access goals efficiently.
A track record of regulatory success across leading medical device organizations.
Present
Founded independent consultancy providing MDR, IVDR, and combination product (Article 117) expertise to medical device manufacturers. Specializing in design control, clinical evaluations, risk management, and regulatory strategy for devices and IVDs.
2019
Led design control team for IVD medical devices using agile/scrum methodologies. Previously QA Engineering Manager, responsible for regulatory compliance, design history files, and quality engineering for blood gas analyzers and acute care diagnostics.
2017
Managed IT, sales/marketing support, and quality systems for Tempus600 point-of-care testing devices. Led MDR transition initiatives and maintained ISO 13485 compliance while supporting international market expansion.
2012
Led type certification management for wind turbines, coordinating with DNV and other certification bodies. Managed cross-functional teams to ensure regulatory compliance across international markets.
2011
Progressive career spanning 7 years: from Software Developer to Approval Manager, Team Leader, and ultimately Head of Development and Quality. Built and led development and QA functions, establishing quality management systems and driving product certifications from ground up.
Deep knowledge across the full spectrum of medical device regulatory requirements.
Comprehensive technical files, GSPR mapping, risk management documentation, and design dossiers that meet Notified Body expectations.
Clinical Evaluation Reports, literature reviews, equivalence assessments, and PMCF strategies aligned with MEDDEV guidance.
PMS systems, vigilance procedures, PSUR preparation, and complaint handling processes that ensure ongoing compliance.
ISO 13485 implementation, internal audits, supplier qualification, and quality system optimization for regulatory efficiency.
EU and US market access strategies, including FDA submissions and coordination with international regulatory requirements.
Regulatory project leadership, stakeholder coordination, and submission timeline management for efficient certification.
Client-centric methodology focused on practical results.
Every engagement begins with understanding your product, market objectives, and organizational context. One-size-fits-all solutions don't work in regulatory affairs.
I don't just deliver documents—I build your team's capability. Understanding the "why" behind regulatory requirements enables better decision-making.
Regulatory compliance should enable business, not hinder it. I focus on efficient, pragmatic approaches that meet requirements without unnecessary complexity.
Complex regulations explained clearly. You'll always understand the status of your project, upcoming milestones, and any decisions needed.