Mediqol

Regulatory

Experts in CE marking, FDA approvals and International regulatory submissions

Clinical

Full service CRO with staff in UK & Europe

Quality

Specialists in ISO 13485:2003 and FDA QSR implementations

EUAR

Ideal EUAR given established European base and expert medical device consulting team

In the blog

Proposed new regulatory requirements for IVD's in Australia
The Therapeutic Goods Administration (”the TGA”) has recently published an overview of its intended new regulatory requirements that will apply to in vitro diagnostics. Having read through the documentation it appears that the major points are:

IVD’s will be regulated as a subset of medical devices and will be subject to a risk based classification system [...]
Mexico
We’ve just finished a project with a client registering a device in Mexico and whilst a post on the full Mexican system might end up at 10 pages I thought it might be useful to provide a very brief analysis of the Mexican regulatory system!
The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is the [...]
Drug or Device? – MHRA issues updated guidance on borderline cases
Directive Bulletin 17 provides updated guidance on the regulatory criteria for considering drug/device borderline products. It also contains a very useful appendix that lists a number of products and clarify’s their classification depending on intended use or mode of action.

Why Mediqol?

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.