Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business.
- I want to bring out a new product, which market should I target initially? Where can I get it on the market the quickest?
- Do I need to perform a clinical investigation to get the product approved everywhere? Can I get it on the market somewhere and gather clinical data to support other markets in that way?
- What is the impact if we move manufacturing of this product or sub assembly to another site?
- What regulations do we have to meet if we make a certain location the regulatory “manufacturer” site?
Answering these types of questions early in the decision process can enable successful business and regulatory planning. Our consultants have extensive experience in assessing these types of scenarios and implementing associated plans.
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›