Regulatory Partners in Innovation

In complex sectors as Health and High Tech specialised knowledge is often needed to be able to advance the business. But as an entrepreneur you do not always have all the necessary knowledge about regulation, IP, design but also finance and marketing available in your company. To help you search for the needed temporary/specialized expertise Briskr has developed an ecosystem of reliable suppliers.

All companies in this database have agreed to the publication of the (contact)data. And it is agreed that first talks (up to 2 hours) are free of charge when you have been transferred by Briskr.

mi-CE consultancy

Regulatory affairs and Quality management system consultant regarding the Medical Device Regulation (MDR EU 2017/745) and In Vitro Diagnostic Device Regulation (IVDR EU 2017/746), ISO 13485, and FDA 21 CFR 820 , 510 (k) requirements for medical devices and in vitro diagnostic devices.


Regulations for market access of medical devices and in vitro

Baelde Consulting

Baelde Consulting offers consulting services focused on the management of Quality and Excellence for Innovative companies in highly regulated industries, such as medical devices.

Baelde Consulting offers personal and tool-agnostic support with the definition and implementation of suitable quality and regulatory provisions for market-access of medical devices in the EU.

Baelde Consulting has long-time experience in the high-tech, automotive and medical industries.