Clinical Research Consultancy

Evidence-driven strategy for MedTech innovators

Rigorous clinical research expertise, regulatory intelligence, and fractional executive leadership — from first-in-human to market access.

EU MDR FDA IDE UKCA ISO 14155:2020 GCP Certified ICH E6
10+
Years clinical research & medtech leadership
3
Regulatory jurisdictions: UK · EU · USA
MSc
Clinical Research & Psychological Sciences · DBA in progress

Scientific rigour meets strategic acumen

Angela M L dos Santos is the founder and principal consultant of Aegis Clinical Strategies — a UK-based sole trader consultancy delivering specialist clinical research and regulatory strategy to the global MedTech sector.

With a decade of hands-on experience spanning clinical trial design, protocol development, clinical evaluation, and the integration of clinical strategy into product development, Angela has guided MedTech innovators through complex regulatory landscapes including EU MDR, UKCA, and FDA submissions.

Her career trajectory — from Lead Physiologist at King’s College Hospital to Clinical Research Scientist at Nevro and Director of Global Clinical Research at Nyxoah — reflects a rare combination of bench-level scientific rigour, GCP-compliant trial execution, and C-suite strategic leadership. Advanced qualifications in Clinical Research (MSc, University of Liverpool), Psychological Sciences (MSc, Brunel), PgCert in Clinical Education (King’s College London), and a DBA in progress at ESGCI Paris underpin a uniquely multi-disciplinary perspective.

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Clinical Trial Design & ExecutionFDA IDE · EU CTA · ISO 14155:2020 · ICH GCP E6
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Alignment between Clinical & Regulatory Strategy and SubmissionsEU MDR · UKCA · FDA 510(k) / PMA · CE marking pathways
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Clinical Evidence GenerationCEP · CER · PMCF · MDCG-compliant documentation
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Fractional Executive LeadershipVirtual CCO · Cross-functional alignment · Scientific communications

Career milestones

July 2025 – Present
Founder & Principal Consultant
Aegis Clinical Strategies
2021 – Present
Director, Global Clinical Research
Nyxoah
2015 – 2021
Clinical Research Scientist
Nevro
2009 – 2015
Lead Physiologist — Cardiac Diagnostics & Clinical Education
King’s College Hospital
2013 – 2015
Guest Lecturer
Middlesex University
2008 – 2009
Chief Respiratory Physiologist
Tunbridge Wells NHS Trust

A sector defined by regulatory complexity

The global MedTech market is expanding rapidly, driven by increasingly stringent regulatory frameworks that demand robust, independently-verified clinical evidence.

UK Market
US$21.6bn
2025 revenue · 5.5% CAGR to 2030. NHS MedTech Funding Mandate and LSIMF grants accelerating adoption.
EU Market
US$172bn
2025 revenue driven by the EU MDR transition and elevated clinical-evidence requirements for all device classes.
US Market
US$200bn
2025 revenue · 5.9% CAGR. FDA pathways driving demand for specialised external clinical expertise.
01
EU MDR Clinical Evidence
Stricter Annex XIV requirements have created significant demand for outsourced CER, PMCF design, and regulatory strategy.
02
FDA IDE, PMA & 510(k)
The FDA expects comprehensive clinical packages across IDE, PMA, and 510(k) pathways. MedTech startups increasingly rely on specialised external expertise for trial design, clinical evidence, and submission support.
03
NHS & UKCA Pathway
NHS innovation programmes and LSIMF funding accelerate UK adoption, but require strong, compliant clinical dossiers to meet UKCA standards and Notified Body scrutiny.

Integrated clinical strategy across the development continuum

From early feasibility through post-market surveillance, Aegis provides the clinical and regulatory infrastructure your programme requires — at the pace your milestones demand.

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Clinical Trial Design
Scientifically rigorous study design grounded in ISO 14155:2020 and ICH GCP E6. Deliverables include IDE/CTA synopses and full protocol development with site feasibility assessment.
IDE SynopsisProtocol
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Clinical Evaluation
EU MDR Annex XIV-compliant Clinical Evaluation Plans and Reports, with rigorous literature appraisal, equivalence analysis, and PMCF design using MDCG guidance templates.
CEPCERPMCFEU MDR
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Alignment between Clinical & Regulatory Strategy and Submissions
A single, integrated roadmap bridging clinical evidence generation with UKCA, CE-mark, and FDA submission pathways. Plans aligned to device classification, risk profile, and commercial timeline.
UKCACE MarkFDA
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Clinical Research Operations
End-to-end trial management: site and patient management, safety monitoring and adverse event reporting, ethics and regulatory submissions, quality assurance, and CSR development.
Site ManagementSafetyGCP
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Scientific Communications
Manuscript development, publication strategy, abstract and congress presentations, and Key Opinion Leader engagement to position your clinical data at the forefront of the scientific literature.
PublicationsKOLCongress
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Fractional CCO
Strategic advisory retainer delivering virtual Chief Clinical Officer-level leadership: cross-functional alignment, clinical data integration into commercial strategy, team mentorship, and regulatory intelligence.
RetainerStrategicLeadership

Ready to build a clinical strategy that accelerates your regulatory pathway?

Request a Scoping Call

Founded on scientific depth

Regulatory
  • EU MDR Compliance
  • FDA Regulations & IDE/PMA/510(k)
  • UKCA Pathways
  • Regulatory Intelligence
  • Investigational Product Dev.
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Clinical Research
  • Protocol Dev. & Study Design
  • Site & Patient Management
  • Safety Monitoring & AE Reporting
  • ICH GCP Compliance
  • CSR, CEP & CER Development
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Evidence & Science
  • Manuscript Development
  • Publication Strategy
  • KOL Engagement
  • Abstract & Congress Comms
  • Regulatory Documentation
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Leadership
  • Strategic Planning
  • Cross-functional Alignment
  • Team Building & Mentorship
  • Risk Identification & Mitigation
  • Change Management

Education

Doctor of Business Administration
ESGCI — Paris
Expected 2028
MSc Psychological Sciences
Brunel University of London
2022
PgCert Clinical Education
King’s College London
2017
MSc Clinical Research
University of Liverpool
2015
BSc Cardiac & Respiratory Physiology
Escola Superior de Saúde Egas Moniz
2008

Certifications & Standards

GCP for Clinical Investigations of Devices
GCP for Clinical Trials with Investigational Drugs & Medical Devices (US FDA Focus)
Good Documentation Practices
HIPAA for Education and Research
GDPR
Connectd Fractional Executive Programme
ISO 14155:2020 — Clinical Investigation of Medical Devices
ICH E6 (R2) Good Clinical Practice
MDCG Templates & EU MDR Annex XIV

Begin your clinical strategy conversation

Whether you are navigating a first regulatory submission, designing a pivotal trial, or seeking embedded clinical leadership, Aegis Clinical Strategies provides the independent expertise to advance your programme with confidence.

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Address
4th Floor, Silverstream House
45 Fitzroy Street, Fitzrovia
London W1T 6EB