Experts in CE marking, FDA approvals and International regulatory submissions
Mediqol is the first choice medical devices consultancy for clients looking for practical advice and support throughout the lifecycle of a medical product from assessing the regulatory pathway, clinical trials and quality system implementations - to product approvals, reimbursement and post-market surveillance.
Reduced time to market
We help clients reduce the time it takes to get their products on the market by using our knowledge of the product development process, medical device legislation and our relationships with the Notified Bodies and Regulatory Authorities
Reduced risk
We reduce the risk of an application being rejected through an in-depth knowledge of medical device legislation, requirements and expectations of Regulatory Authorities
Reduced cost
We save our clients money by managing the regulatory or clinical process and recommending effective strategies which will ensure approval with the minimum of resources
Expert team
With an expert team assembled from Departments of Health, Notified Bodies and industry we believe we have more medical device knowledge than any other specialist medical device consultancy in Europe
Full lifecycle assistance
We can provide assistance throughout the entire lifecycle of a medical device, from its initial conception and product feasibility right through to clinical trials, regulatory approval and post-market surveillance.
