Michael is Co-Founder of anteris medical. He is a medical device professional with more than 12 years’ experience in mid-size and global biotech and device organizations in the fields development, quality and regulatory affairs…
We connect the dots –
so you can focus on your business.
We focus our efforts on supporting clients who either lack resources familiar with medical device development or wish to complement their existing resources.Schedule your free consultation Too much on your plate? Get in touch!
Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820
In vitro Diagnostics
- Structured user centered concept development
- Innovative requirements management - reduced burden of documentation and improved traceability
- Patient preference studies
- Partner network for industrial design, mechanical design, hardware and software design
- Supplier evaluation and audits
- Establishment of EU and US compliant development processes and documentation
- Implementation of risk management processes according to ISO 14971
- Moderation of risk management meetings
- Usability engineering and local support for US or EU handling studies
- Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
- Identification and analysis of relevant clinical data
- Clinical Investigations
- Design transfer of development specifications into production and QC specifications
- Project management for upscale projects
- Established partnership for commercial production
- CMO selection and control (audits)
- Audit preparation support
- Remediation projects after audits
Marketing and Sales
- Market research support
- Proven go-to-market strategies
- US-based partnership for market entry strategy, including operations
Service and Customer Feedback
- Professional capture of market feedback for next round of product development
- Compliant processes for post-marketing surveillance
Design Change Projects
- Design History File (DHF)
- Device Master Record (DMR)
of anteris medical
Requirements and Risk Management for Combination Products
Ready for combination products
Comes with a pre-compiled catalog of requirements and risks specific for combination product development.
Intuitive & Fast
Without any training or setup needed, you will be able to quickly ensure full traceability and create reports for your technical file and design history file.
Complete, Adaptable & Scalable
Covers all documentation necessary to fulfil compliance to standards combined with the flexibility to be adapted to your specific needs.
Meet the team
Thierry is the General Manager of anteris helvetia. He has more than 12 years’ experience in injection devices and combination products for various application such as diabetes, Parkinson disease or hormone therapies.
He has a focus…
Bernd has more than 25 years’ experience and expertise in IVD, medical devices, infectious disease diagnostics in the areas of marketing, product management, communication, laboratory automation, R&D and IT.
He is a co-creator and…
Peter is a senior project manager for medical device development and quality management system projects.
He has more than 15 years of experience in mid-size and global medical device and pharmaceutical companies with international…
Maical is a medical device specialist with more than 6 years’ experience in global and mid-size medical device organizations in the fields development, quality and regulatory affairs.
In his previous role as manager R&D (medical…
Eva is a life scientist and medical device professional with experience in mid-size and global medical device and pharma companies since 2006.
She is safety officer, risk manager and medical device consultant with an in-depth…
Barbara has more than 13 years of global pharma labeling experience.
She has a strong focus on biosimilars and combination products, profound regulatory labeling experience in development and maintenance of complex generics,…
Nina is our Marketing Specialist with more than 5 years’ experience in this field.
In her previous role and with the receipt of her bachelor’s degree in marketing & communications management she had several positions as Product and…
Sandra is a specialist for Regulatory Affairs and Product Development including drugs, drug/device combination products and medical devices. She has gained experience from small to big global pharma and medtech companies with focus on…
Piotr is a Senior Project Manager with 10 years of experience in the industry. His background is in Industrial Biotechnology, Packaging Technology and Brand Management.
During his career he has led multiple New Product Development…
Monika is a specialist for design control of combination products and medical devices. As a medical engineer, she has gained experience during specific projects with different industry partners of medical devices at the university. Her…
Fabricio is a specialist for design control of combination products and medical devices. He has gained experience during specific projects in university as a medical engineer in different fields, besides Biology and Physiology, also…
Rahel is a biomedical engineer with more than 10 years of experience in the medical device industry and in-depth knowledge of drug/device combination products.
She is a PMP certified project manager and has led projects from ideation…
Lina has 10 years of international experience working along the medical device development pipeline in leading pharmaceutical and diagnostics industries.
She specialized in medical devices and combination products, planning…
Tabea is medical device specialist in the fields of usability engineering for combination products and medical devices since 2018.
She has gained experience from small to big global pharma and medtech companies with focus on…
Astrid is a Human Factors Engineering (HFE) expert with 20 years’ experience in start-up, international mid-sized medtech as well as global pharma companies. She has the understanding of the full development process involving HFE in…
Jenny is a medical engineer with a focus on design control. During her studies she gained knowledge in biology and chemistry as well as in Quality Management (ISO 13485), Risk Management (ISO 14971), Usability Engineering (ISO…
Leonie is a specialist for Project Management in the development of Medical Devices and Combination Products. She has gained experience in global pharmaceutical companies, managing the development of mechanical pen-injector and…
Alexa holds a MS Sc in Biomechanics and a teaching diploma from ETHZ and has more than 12 years experience as product and project manager in the medical devices industry.
Being responsible for product development, industrialization…
Christoph holds a BSc in Micro and Medical Technology and has over 10 years experience in development and project management of medical devices and drug device combination products and more than eleven years of experience with overall…
Bruno is a device development manager with proven track record covering full life cycle management of combination products.
Hands on experience in combination products transfer with wide set of skills needed to overcome rising…
Huda is a medical engineer with a focus on Risk Management (ISO 14971) and Medical Device Regulation. During her studies she gained knowledge in biology and chemistry as well as in Quality Management (ISO 13485), Usability Engineering…
Smita is a scientist by training and regulatory affairs manager by profession. She is specialized in late phase clinical trials and post market observational/surveillance studies with drugs and medical devices.
She was leading the…
Yannick is a combination product and medical device expert with more than 6 years of experience in global medical device and pharma companies.
Being responsible of the design and process development of medical devices and combination…