Regulatory and standards compliance support
Training in market awareness communications
Throughout the organization and in its interaction with distributors, a better understanding of the regulatory environment can greatly improve documentation compliance and speed to market. MDCPartners helps with coaching and training individuals and departments from RA/QA to commercial managers.
Compliance to medical standards is a specific critical business need, often only understood in a late phase when tender requirements or external audits point out the existence of certain critical standards. MDCPartners helps with understanding this process, training the functions that deal with quality document management and standards monitoring.
Liaison with standards committees
Standards monitoring also implies that as a company and expert in your field, you can help drive or influence the standards development processes at CEN or ISO. MDCParters has experience in navigating the standardization setting process, identifying committees and supporting the technical process of standards writing with your appointed experts.