Medical Devices Consulting
The Regulatory, Quality and Engineering consultants for Medical Devices that integrates into your company workflows
Simplify your processes and accelerate compliance
Tools & methods tailored to your company’s culture and strategy
Multidisciplinary agile experts who can fill various positions across your organization from engineering to C-level, and board level positions.
Straight to the point approach that meets the standards without the headaches.
Our team is familiar with regulation such as 21 CFR 800, ISO 13485, MDSAP & more.
Medical Device consulting services
ON-DEMAND
CONSULTANT/EXPERTS
Whenever you need talents without the HR processes : our experts can fill various positions in your organization from engineer to executive and board level positions.
The Flexibility and the expertise at the tip of your fingers.
QUALITY & REGULATORY
QMS design & improvement : from writing and implementation to continuous monitoring a and upgrade. We accompany your journey from DHF remediation to regulatory approval.
Tailored and up to date solutions while ensuring regulatory compliance.
MEDICAL DEVICES
ENGINEERING
Wether you need to scale-up your products or a device qualification, we bring a comprehensive diagnosis of your supply chain or developpement issues to optimized solutions.
Save time, reduce risks, and accelerate your innovation.
Let’s Discuss Your Project
You have a medtech project in mind? Let’s talk today to find the perfect solution for your needs.
Your Trusted Medical devices Consulting Partner
We support medtech companies in managing their regulatory quality and engineering for medical devices needs. Because of our flexible approach and expertise, you can focus on what matters the most: innovation and growth.
We are based in Geneva, active in Switzerland, France, Europe, and beyond.
GETTING CERTIFIED IS INDEED THE GOAL, BUT QUALITY IS THE JOURNEY
When focusing only on the technical performances of their medical devices, companies often underestimate the hurdle of quality audit and product certification, delaying their market approval.
What if you could integrate compliant processes seemlessly to your workflow today ?
Save time and effort for your future project milestones, starting today.
Benefits of a tailored medical devices consulting
We provide what your project really needs.
- Quick access to Medtech competencies
- No Human Resources commitment
- Low impact on your burning rate
- Customized support
Don’t wait for your project to bloom
Let’s get in touch to help your medtech journey