MeddiQuest Limited - Regulatory Affairs Management

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In Vitro Diagnostic Devices
Diagnostic Devices and Equipment

Mission

to partner customers in finding simple and effective strategies for regulatory compliance, which enhance their normal business operation.
to help reduce the uncertainty of inspections and audits by:
- conducting dummy inspections
- reviewing procedures
- assessing risk
- prioritising actions

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:

treat every contract as a project:
agree the scope and deliverables
agree a service level (if appropriate)
agree a project plan
agree a price
provide regular updates on progress
agree any deviations or extensions
update the plan if required

Meddiquest is committed to forging links between the device and biologics communities; we are members of Medilink East Midlands, ERBI and Medilink East.

Activities

International listings and registrations
510(k), PMA, PDP, technical file review
CE marking
IVMDD Compliance
Testing and trial management
Labelling and DFU's

We can also provide support on:

Adverse incident investigations
Processes, facilities and equipment
Clean and controlled environments
International transfers
Assessment and validation
Systems, MRP/ERP and procedures
Packaging, labelling or sterilization
Training and auditing

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.