Service Offerings
Medtech Compliance Consult works on an hourly or daily rate basis on time-bound projects with clear objectives and deliverables. In addition to practical support or independent advice on a wide range of topics in the field of regulatory affairs and quality management, Medtech Compliance Consult offers six specific services.
Compliance Deepdives
This service is designed for companies that need an independent, third-party assessment of the organization's compliance status and culture. On the basis of stakeholder interviews, reviews of processes, organizational structure and KPIs, an analysis of the company's strengths and weaknesses in the field of compliance is made. Based on this, you will receive advice on which priorities to set in terms of improvement, and where more flexibility is possible without taking unacceptable compliance risks.
Due Diligence Support
The target group of this activity are institutions and companies that are considering buying or selling a medical device company. This service includes the systematic identification of quality and regulatory risks of the business to be bought or sold, along with providing sound advice on options to mitigate these risks.
Strategy Development
This activity is the core business of Medtech Compliance Consult. On the basis of a detailed compliance deep dive and study of the business strategy, a multi-year plan on quality assurance and regulatory affairs is developed together with the stakeholders with the aim of creating a compliance environment in which optimal business growth is possible within the framework of the regulations.
Interim Management
This option is intended for companies where there is a leadership vacuum in the organization for a number of months.Use the time before your new quality and/or regulatory affairs manager starts effectively by hiring Medtech Compliance Consult as an interim manager and at the same time have a compliance deepdive performed. This will keep the momentum going and get your new hire off to a flying start.
Mentoring
As a person with final responsibility for quality assurance and/or regulatory affairs, you may sometimes feel the need to reflect on your uncertainties, ideas, strategies and choices in a safe environment with someone who knows your field through and through. Medtech Compliance Consult offers you that safe environment and 25 years of experience in quality assurance and regulatory affairs.
Expert Advice
Obtain practical support or independent advice on topics in regulatory affairs and quality management that are critical to the success or failure of the business.