We are delighted to work with some of the most innovative companies in the Medtech-Industry
CASCINATION AG is an award-winning medical technology company from Bern, Switzerland dedicated to the development, manufacturing and commercialization of innovations in computer-assisted and image-guided surgery.
What we do/did: BlueBroccoli prepared 510(k) submissions for a surgical planing software and supported the Taiwan market access by identifying and engaging with distributors.
BlueBroccoli provided great support and took a lot of work off our hands, and the results speak for themselves.
Lukas Heumos – CASCINATION Head of Regulatory and Clinical Affairs
RetinAI Medical AG
RetinAI, founded in early 2017 in Bern, develops software solutions to accelerate clinics, research and pharmaceutical workflows globally using advanced machine learning and computer vision.
What we do/did: Blue Broccoli built the quality management system according to ISO 13485 and MDR and supported the company for their initial notified body audit. We carry out internal audits and act as EC-REP.
We are very happy with the outcome and support received to develop our Quality Management System by Blue Broccoli, our collaboration was the foundation of our current Quality System, which has enabled us to achieve regulatory approvals in the European market and beyond.
Enisa Dresevic – Retinai Head of Regulations & QA
Bottneuro is a spin-off of the University of Basel working on digital diagnostic solutions and non-invasive treatments for Alzheimer’s Disease (AD). The Bottneuro team consists of biologists, materials scientists, engineers, data scientists, physicists and psychologists, and is backed up by highly experienced advisors and entrepreneurs.
What we do/did: Blue Broccoli establishes the quality management system, supervises the product and process development for compliance, and guides through the clinical study and market approval process.
BlueBroccoli hat uns von Anfang an begleitet und ist ein sehr zuverlässiger Partner und unsere rechte Hand in Sachen Regulatory und QMS. Wir sind sehr froh, weiterhin auf David Eiler zählen zu können.
Bekim Osmani – Bottneuro CEO
L2F SA – Giotto Compliance
Giotto Compliance is developed by L2F SA, a Swiss technology company that was born in 2017 at the EPFL. Their AI-Based proprietary technology has been awarded multiple grants by the Swiss Innovation Agency and won several eminent competitions worldwide.
What we do/did: BlueBroccoli is a happy user of Giotto Compliance in several CERs. On a consultancy base Blue Broccoli reviews and advises on the product functions and roadmap.
We rely on Blue Broccoli as a partner for their proven expertise in certification processes for medical devices. Their deep knowledge of regulatory requirements and understanding of software development processes is a key factor for the success of our Product Management activities.
Francesco Palma – L2F Vice President Product
A dental care and oral health start-up founded by scientists, supported by international investors, driven by young talents who share the same vision and believe in the power of scientific knowledge.
What we do/did: Blue Broccoli consults the Bottmedical team on quality and regulatory strategy and advises on medical device design and manufacturing processes. Blue Broccoli works on specific appointed projects such as the CER and FDA submissions and acts as EC-REP.
Blue Broccoli is highly flexible to execute projects with startups in the early stages. Professional knowledge with hands on approach and the ability to find the most burdenless and suitable regulatory strategy.
Tino Töpper – Bottmedical CEO
GalvoSurge Dental AG
GalvoSurge Dental AG is a Swiss-based manufacturer for design, development and distribution of dental devices and equipment for Surgical periimplantitis therapy. GalvoSurge was a finalist of the Swiss Medtech Award 2021
What we do/did: Blue Broccoli supported the MDSAP transition project, carries out internal audits, advises on new product development and acts as EC-REP.
We are a
Swiss Medtech is the association of Swiss medical technology that represent around 700 companies. Swiss Medtech was established in the summer of 2017 following the merger of two organisations to become an association based in Bern. Swiss Medtech is a member of the European umbrella organisation MedTech Europe.