Strategy Business/Regulatory/Clinical Pathways

As a starting or experienced company in the Medical Device or in Vitro Diagnostic field you want to enter the market as soon as possible. However, you are not fully aware of all the regulatory requirements necessary to start selling tommorrow.

 

mi-CE consultancy offers complete business, regulatory, clinical strategy consultancy services for medical device and IVD manufacturers for compliances according to the regulatory requirements world-wide.

 

Which STRATEGY is wise for your product to follow:

• Focus on Europa initially and the rest of the world later? 

• Or first focus on the USA and include Canada?

• Which classification has your product? Which intended use and mode of action? Can you product be used in different clinical applications areas therefore changes in classification is possible?

• Should your company have an ISO 13485 certification or is complaince to the MDD Annex II or V good enough?

• Should your outsourced production location have a ISO 13485 or ISO 9001 certification or not? 

• Which Notified Body should we consider for application for the CE approval? What are the differences between the Notified Bodies and the timeframes and costs for reviews. Which other aspects are important for selection of a proper notified body for your company?

Overall, these are some initial questions you as a company may have, and many more questions may arise. 

mi-CE consultancy can help you with answering these questions and clarify all the business/ regulatory and clinical strategy pathways involved.

A well designed regulatory strategy pathway considers not only complaince to the medical devices regulation, but also research and development design, subcontractor control and overall costs and profitability concerns. 

Our consultants have extensive experiences in full value-based portfolio analysis throughout the life cycles of products. Additionally the knowlegde of the regulatory requirements world-wide is robust in our team.

 

mi-CE consultancy's goal is to provide you with a clear understanding of the types of regulatory, business and clinical trials requirements you will encounter as you work towards the launching of your medical devices or IVDS in the market.

 

mi-CE consultancy will define a strategy together with you that will move your device allong the appropriate pathway more easily and reduce the time and cost to bring your product to the market and meet your ultimate goal of bringing a safe and effective medical device to the patient.