Initializing Swiss Precision...

Precision as Absolute.

Navigating the development, regulatory and commercialization path for devices that define the margin between success and failure in interventional medicine.

Swiss Scenery

THE PEOPLE

Our team unites biomedical engineers, regulatory affairs specialists, and clinical strategists under one roof to deliver comprehensive solutions.

Meet The Team
Clean Room Environment
25+
Years Experience
EU/US
Market Access
ISO
13485 Specialists
Full
Lifecycle Support

Trust

PREVIOUS CLIENTS

Essity
Essity
Johnson & Johnson
Johnson & Johnson
Julier Medical
Julier Medical
Ypsomed
Ypsomed
Karl Storz
Karl Storz
Spinesave
Spinesave
Physeon
Physeon
Swiss Alps Background
01 / The People

NO MARGIN
FOR ERROR.

Our philosophy is binary: A device functions perfectly, or it is rejected. There is no middle ground in the operating theatre.

Multidisciplinary Expertise

Our team unites biomedical engineers, regulatory affairs specialists, and clinical strategists under one roof to deliver comprehensive solutions.

Strategic Insight

We don't just execute; we anticipate. Our collective experience allows us to foresee regulatory bottlenecks before they arise.

Operational Excellence

From initial concept to post-market surveillance, our operational rigour ensures seamless and compliant project execution.

Niall Behan
Founder and CEO

NIALL BEHAN

With over two decades defining the cutting edge of the medical device industry, Niall Behan stands at the intersection of rigorous engineering and complex regulatory strategy.

His career is built on a dual competency that is rare in the sector: the technical foresight to engineer viable solutions, and the regulatory command to ensure those solutions reach the market. From early-stage R&D to global compliance frameworks, Niall provides the seasoned authority required to navigate the modern medical landscape.

25+
Years Experience
Dual
Reg & Eng Expertise
Principal Consultant

LEON GLEESON

Leon Gleeson is a seasoned medical device executive, bringing extensive experience in product development, verification & validation, and regulatory-compliant design within the med-tech sector.

With a strong background in guiding complex devices from concept through to commercial readiness, he plays a central role in translating innovative ideas into robust, manufacturable, and standards-aligned products. Leon leads cross-functional development activities, manages technical documentation in line with EU MDR and international regulatory expectations, and supports clients in navigating design controls, risk management, and performance validation. His combination of hands-on engineering capability and deep understanding of regulatory frameworks makes him a trusted technical partner for organisations seeking to accelerate development while maintaining rigorous quality standards.

Leon Gleeson
Niall Grenham
Principal Consultant

NIALL GRENHAM

Niall Grenham is an experienced and self-motivated medical device engineering professional with over two decades of experience in the medical technology sector. He has a strong track record in new product introduction, quality engineering, and delivering regulatory-compliant medical devices that meet stringent international standards.

Niall’s expertise spans the full product lifecycle, from early concept and design through to verification, validation, and launch — with a deep understanding of risk management, design controls, and quality systems. Known for his ability to bridge technical execution with strategic regulatory insight, he supports organisations in navigating complex compliance landscapes while driving development efficiency and product excellence. His long tenure in the field and proven problem-solving capabilities make him a trusted leader and collaborator in med-tech innovation.

02 / Regulation

REGULATION AS
FOUNDATION.

We do not view regulation as a hurdle, but as the blueprint for excellence.

03 / Contact

INITIATE
DIALOGUE.

Headquarters

Wallisellenstrasse 28A
8600 Dübendorf
Switzerland

Direct Line
+41 78 826 86 45