MeddiQuest Limited - Regulatory Affairs Management

Site Map Devices Home Page Software-Substances Combination Products
Our Team Our Services Our Seminars Our News Contact Us

In Vitro Diagnostics Regulation

The change from directive to regulation will have a major impact on In Vitro Diagnostics, because the vast majority of products which have to date required no monitoring from a Notified Body (NB) will now require a risk based degree of Notified Body oversight. Coupled with the recognition of Companion Diagnostic Devices and the need for specific staff to act as a device-responsible persons, the existing resources of many companies and Notified Bodies are going to become very stressed in the next few few years - as if they would not be anyway just by the growth in market.

Our recommendation is to plan early and be prepared to adapt under the onslaught of implementing legislation predicted over the next few years. We at MeddiQuest are ready to help you set a survival strategy through these traumatic times for IVDs!

In Vitro Diagnostic Devices
Diagnostic Devices and Equipment


Special Products, Special Skills

Regulators may treat in vitro medical devices as a coherent group, but in reality they encompass a diversity of products: complex electronics, exotic materials, simple, well known chemical tests, or sophisticated reagents.

MeddiQuest combines drug and device expertise in a full service for IV Devices and Drug-Device combinations. Whatever your product mix, we can provide the expertise and experience to manage your regulatory affairs or supplement your own valuable internal resources

Guarding Competitive Advantage

The workload of the typical regulatory affairs department tends to be "peaky" - MeddiQuest can provide the extra resource and expertise to cover those peaks of intensity and urgency, thereby allowing your internal resource to be dedicated to the tasks for which they are more specially equipped. Tasks will be completed and timescales met.

Let us turn your RA "bottleneck" into your competitive advantage by providing an additional highly skilled resource that you can switch-on at will.

It's like having the right number of RA staff ... at all times!

Reducing Time to Market

Proactive management of regulatory affairs ensures that bottlenecks are avoided by assessing risks and completing activities in parallel wherever possible.

Investing in a regulatory strategy review at an early stage is the key to ensuring that your RA activities promote your competitive advantage, and leverage the compound benefits of being first to that hard-won market.

Working Together

Our dedication is to be your business partner, working with you to build a long term relationship. We aim to:

Meddiquest is committed to forging links between the device and biologics communities.


We can also provide support on:

Key Personnel

Dr Ian Duncan and Neil Armstrong enjoying some "in-vitro" testing! Neil Armstrong and Ian Duncan work closely together on In-Vitro products. Neil says I find this very stimulating; Ian has a life science approach, mine is that of an engineer and physical scientist. Together we can really highlight the issues poised by these products and seek creative solutons. The diversity of products is such that one of us can almost always share an new insight with the other.

Site Map Devices Home Page Software-Substances Combination Products
Our Team Our Services Our Seminars Our News Contact Us

email us at
Uploaded April 21, 2006
Last updated October 23, 2015
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX