Sci-Lutions

Ltd

Scientific Solutions: Where Innovation Meets Insight

In Association with PQE Group

Our Mission

Sci-Lutions Ltd is a premier medical device focused consultancy, offering a comprehensive suite of services designed to support the entire product lifecycle from concept to medical training.

Our expertise encompasses regulatory compliance, navigating complex submission packages to FDA, EU-MDR, NMPA, TGA, Health Canada and others.

We collaborate closely with our clients, often as an extension of their teams, to navigate complex regulatory landscapes and enhance the safety and effectiveness of medical devices. Our deep regulatory expertise, scientific rigor, and agile approach ensure we deliver solutions that not only meet compliance requirements but also exceed expectations and support better patient outcomes.

We provide detailed guidance on biocompatibility and chemical-material safety evaluations, risk-based assessment pathways and complex extractable and leachable test plans for primary material substitutions.

We also offer direct lines to ISO17025 compliant CRO's with fast track test options for emergency deficiency resolutions and to ensure technical documentation support, enabling clients to successfully bring innovative medical devices to market and maintain compliance throughout their commercial lifespan.

Services

Medical Device Design Risk Management
Education & Training Plans
Compliance Assurance
Bespoke training model design & manufacture

Specialism

Oncology
Acute therapies
Renal/Haemodialysis
Obesity
Vascular Interventions
Interventional Oncology
In Vitro Diagnostic Devices
EU-MDR 2017/745

Operations

EMEA
APAC
US

Our Clients

Dear Marcus,

It has been a pleasure working with you on MDR submissions and addressing review cycle questions from TUV. I have greatly appreciated your quick responses, your commitment to finding solutions and alternative approaches, and your valuable support during the submission process.

I have always found you to be approachable and responsive, especially when it comes to explaining technical matters. Your openness to teamwork and dedication to the team’s goals have made a positive impact.

Thank you for all your good work and support.

Dinesh at Baxter

Meet the Team

Chief Scientific Officer

Dr Marcus Caine

PhD. CEng. MIMMM. MIoD.

Dr. Marcus Caine, PhD, CEng, MIMMM is a distinguished leader at the intersection of materials science, medical devices, and innovative drug-delivery systems. Serving as Chief Scientific Officer of Sci-Lutions Ltd, he spearheads scientific consulting tailored for medical device chemical safety, R&D strategy, and government consulting services.

Dr. Caine brings over 16 years of medical device industry expertise, including roles at major firms like Boston Scientific, Baxter Healthcare, and BTG PLC. His focus spans interventional oncology, acute renal dialysis, thermography, and peripheral vascular thrombolytics

Academically, Dr. Caine holds a PhD in predictive drug delivery to tumours, developed using both in vitro and in silico models and is a core advisor to the newly formed Centre of Excellence for In Silico regulation in the UK. He is a Chartered Engineer and Member of the Institution of Materials, Minerals and Mining (MIMMM) and active member of the Institute of Directors London.

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Chief Marketing Officer

Mrs Maral Caine

FdSc. Cert.Rad. Cert.Ortho

Maral Caine leverages over 13 years of clinical and compliance expertise in dentistry, orthodontics, and pharmacy to craft clear, trusted marketing strategies for Sci-Lutions Ltd. With a rare blend of technical knowledge and creative communication skills, she bridges the gap between complex healthcare innovations and the professionals who use them.

Having managed and trained dental teams, overseen CQC compliance, and implemented high-standards across multiple practices, gives her clinical expertise with strong leadership.

She is also certified in radiography, orthodontics, facial aesthetics, and phlebotomy. In addition, Maral also brings almost 8 years of pharmacy experience as a qualified dispenser in both hospital and community settings. This dual background in dentistry and pharmacy gives her a unique perspective on patient care, safety, and compliance.

Sci-Lutions

Ltd

Scientific Solutions: Where Innovation Meets Insight

In Association with PQE Group