Leadership Team

Meet the people leading your engagement.

Every MediLife Digital Health engagement has direct senior-level involvement, bringing regulatory and engineering expertise together throughout delivery.

Meet the Leadership Team

CTO, MediLife Digital Health

Mark Vaughan

Experience: 20+ years in healthcare technology
Discipline: Software engineering & delivery
Standards: IEC 62304, ISO 13485, ISO 14971
Credentials: PhD (Engineering)

Mark has spent over twenty years building software-based medical devices and digital health platforms, and leads MediLife's engineering capability.

Mark works inside client engineering teams rather than alongside them — brought in when architecture decisions are being made, when a QMS needs rebuilding at scale, or when a programme has stalled and needs a technical lead who can also speak to regulatory consequence. He's most valuable early, before technical debt becomes regulatory debt — but just as valuable rescuing a programme that's already in trouble.

Recent work

Conducted a year-long review of a life-sciences instrumentation company's software development processes and rewrote its software quality management system end to end.

Software architecture
IEC 62304 delivery
AI-enabled systems
Programme leadership

Director, Regulatory Affairs & Compliance

Ana Burman

Experience: 25+ years in healthcare & technology
Discipline: Regulatory strategy & quality
Credentials: PhD (Brunel), CISSP

Ana works across medical device regulation, quality management and digital health, building regulatory strategy and quality systems from first principles.

Ana is brought in to define a regulatory strategy before a QMS exists, to independently assess documentation before a formal review, or to take over a submission that's stalled. She brings the greatest value when regulatory strategy needs to be set early — and just as much when it needs to be repaired.

Recent work

Led regulatory strategy for a professional services firm's digital health venture, securing MHRA registration for its clinical decision support system and bringing its referral management product to the UK market.

Regulatory strategy
ISO 13485 QMS
MHRA & EU MDR
Post-market compliance

Group leadership

Supported by MediLife Ltd group leadership.

Group CEO, MediLife Ltd

Ian Galloway

Business development lead across the MediLife group. Commercial strategy and partnerships across UK and EU MedTech commercialisation.

Chief Commercial Officer

Paul Rowe

Commercial leadership across the MediLife group, coordinating delivery, commercial infrastructure, and cross-unit execution.

How Their Expertise Complements Each Other

Two disciplines. One outcome.

Many consultancies scope an engagement with senior people, then hand delivery to a broader team. At MediLife, the leaders you meet at the outset remain hands-on throughout — reviewing findings, making judgement calls, and staying accountable for the outcome.

Engineering leadership ensures it's built correctly; regulatory leadership ensures it gets approved and stays on market. Most engagements sit in the middle, where engineering and regulatory judgement inform each other in real time — which is exactly where having one integrated team changes the outcome.

Every engineering decision has regulatory consequences. Every regulatory decision has engineering consequences. We make both together.

Work directly with the people above.

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