Compliance expertise for
your MedTech device

Navigate increasingly complex demands to secure approvals, prove impacts, anticipate reimbursement, generate practitioners and stakeholders’ enthusiasm.

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PLAN AHEAD

Regulatory affairs and quality assurance

Tackle regulatory clinical milestones with confidence and clarity. Our team will steer you through each challenge, enabling you to secure appropriate approvals in a timely fashion.

• Upstream identification of likely regulatory classification
• Requirements and processes for individual regulatory classes
• Clinical strategy advice for regulatory approval dossier submission
• Clinical data gathering and evidence preparation

Regulatory affairs and quality assurance
Clinical development and post-market surveillance
SECURE APPROVALS

Clinical development and post-market surveillance

Ease the journey to EU MDR and UK CA approval with a well-coordinated approach designed to minimise disruption at every turn.

• Site identification and protocol development

• Detailed and robust ethics submissions

• Sound methodologies for clinical evidence gathering

• Device value demonstrations

• Ongoing post-market surveillance for corroborating clinical evidence

ANTICIPATE FINANCES

Health economics and reimbursement

Untangle the details and get to grips with reimbursement and coverage models, and impact assessments that can secure your entry to critical markets.

Impact demonstrations at every stage of the patient journey

Economic model development for market success

Specialist reimbursement expertise and guidance

Health economics and reimbursement
MD Medical devices Medical communication and marketing
BUILD TRUST

Medical communication and marketing

Learn how to effectively educate and enthuse medical practitioners already overwhelmed by a mounting list of pressures. 

Understand how to anticipate the change required

Build credibility with peer-reviewed publications

Broaden visibility through podium presence and digital leverage

Our promise

At every stage, our team and trusted partners will only ever work to help you more effectively:

Anticipate icon
Anticipate

your market opportunity

Achieve icon
Achieve

your key development milestones

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Accelerate

your growth

MD Medical Devices talk to our team

As we like to say...

You know your product.
We know the journey.