Medace offers a working environment where entrepreneurial researchers transfer into researching entrepreneurs with high-quality product development and pilot production facilities and with quality and regulatory support for market introduction of medical devices.
One of the challenges that medical device startups are facing when bringing medical devices to the market is the high degree of regulation in the EU market for such devices. For most of these devices, dependent on their risk level, the European Medical Device Regulation (EU-MDR – 2017/745) requires the manufacturer to deploy a certified Quality Management System (QMS). To effectively support these startups Medace offers them a universal and medically certified QMS that clients can use and customize to their specific needs.
Baelde Consulting has been requested to work with the Medace team to revise and implement the tools required (Risk Management, Design & Development, CE labeling, Post Market Surveillance and Auditing) for clients to effectively bring their products to the market.
“Willem worked together with the Medace team on two major projects: bringing our risk management procedure to the next level and implementing MDR guidance documentation for our medical device clients.
In doing so, he always kept focusing on the purpose and scope during the set-up of procedures and instructions. Relying on his broad experience and expertise, he delivered a quality job in drafting documents at the right level, without compromising on regulatory compliance. Furthermore, Willem is a very pleasant and professional person to collaborate with which made everything run smoothly.”
Gertjan Geelen, Quality Manager Medical Devices