We find simple solutions in a complex and regulated industry
LEAN Compliance offers consultancy services within the pharma- and MedTech industries with professional expertise in medical devices, in vitro diagnostics and drug-device combination products.
Consulting services for small and large companies
Our consultants have professional expertise in medical devices, in vitro diagnostics and combination products and cover everything from small tasks to major projects.
Compliance hotline and regulatory assistance
Do you need urgent support or help with a minor emergency? Then contact our compliance hotline. A specialist is ready to assist you.
Advice and support for distributors and importers
The new regulations place greater demands on distributors and importers of CE marked products. Let us help you get there.
Consulting services for small and large companies
Our consultants have professional expertise in medical devices, in vitro diagnostics and drug-device combination products and cover everything from small review assignments to major development projects.
Compliance hotline and regulatory assistance
Do you need urgent support or help with a minor emergency? Then contact our compliance hotline. A specialist is ready to assist you.
A few words about us
Who are we?
Managing Director and Partner
Lene Ultved
Lene has a background as QA Manager and Vigilance Specialist at Agilent Technologies and has built up extensive knowledge in the production, marketing and monitoring of medical devices and in vitro diagnostics. Through her work at Novo Nordisk, she has developed a passion for processes and has successfully implemented efficient and simple procedures adapted to the company's needs and work culture.
Managing Director and Partner
Pernille Eilersen
Pernille is a specialised generalist in medical devices and in vitro diagnostics with a great ability to understand regulatory requirements and translate these into work processes. She is often the "go-to" person, not only because of her QA/RA knowledge, but because of her strong supporter personality acquired through previous roles in Agilent Technologies and Widex.
Managing Director & Partner
Lene Ultved
Lene has a background as QA Manager and Vigilance Specialist at Agilent Technologies and has built up extensive knowledge in the production, marketing and monitoring of medical devices and in vitro diagnostics. Through her work at Novo Nordisk, she has developed a passion for processes and has successfully implemented efficient and simple procedures adapted to the company's needs and work culture.
For me, the word "why" is essential. If a company or its employees never question their behaviour, workflows or processes, how will they ever improve.
Lene Ultved
Adm. Director
LEAN Compliance ApS
mail@leancompliance.dk
+45 60 61 20 82
CVR: 42598224