Our Services

Tailored consulting for medical device innovators seeking clarity and compliance.

Strategy

We help you map out development pathways for quality deliverables.

A consultant discussing regulatory strategy with a medical device team around a conference table.
A consultant discussing regulatory strategy with a medical device team around a conference table.
Compliance

Guidance on FDA and international standards to keep your device on the right track.

Risk management support to identify and mitigate potential product challenges early.

Support
Close-up of hands reviewing medical device documentation and compliance checklists.
Close-up of hands reviewing medical device documentation and compliance checklists.
A professional consultant providing one-on-one advice to a medical device startup founder.
A professional consultant providing one-on-one advice to a medical device startup founder.

Who We Are

At Pelybon Consulting, we bring deep medical device expertise to help your projects succeed.

A focused team meeting in a bright, modern office discussing medical device strategies.
A focused team meeting in a bright, modern office discussing medical device strategies.

30+

3

Multinational Companies

Years of Experience

About me

§ Dedicated and accomplished Quality Engineer & Project Management Professional with extensive experience in the design, development, and industrialisation of medical devices and combination products. Proven ability to manage complex, cross-functional projects from early concept through to market launch, with a strong foundation in Design Controls, Risk Management, and regulatory compliance.

§ Demonstrated success in applying Design Control principles and Risk Management principles across multiple product lines, including complex surgical instruments and spinal implants.

§ Adept at driving cross-functional collaboration across time zones and consistently delivering compliant, high-quality products. Recognised for analytical problem-solving, solution-oriented mindset, structured decision-making, and a collaborative leadership style that drives cross-regional teamwork and continuous improvement in highly regulated environments.

Experience

Senior Program Manager (Quality)
Senior Quality & Operations Manager & Engineer

Medtronic 2010- 2025

Senior Project Engineer
Project Leader Inhalation Devices

Novartis Pharma 2006- 2010

Design Engineer

Sanofi-aventis 1995-2006

gray computer monitor

Contact Us

Reach out to pelybon consulting for expert guidance.