Watch the video

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!

Process

Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820

Combination Products
Medical Devices
In vitro Diagnostics
Development
Commercialization
In Use

Development

Concept
  • Structured user centered concept development
  • Innovative requirements management - reduced burden of documentation and improved traceability
  • Patient preference studies
Design
  • Partner network for industrial design, mechanical design, hardware and software design
  • Supplier evaluation and audits
Design Control
  • Establishment of EU and US compliant development processes and documentation
Risk Management
  • Implementation of risk management processes according to ISO 14971
  • Moderation of risk management meetings
Human Factors
  • Usability engineering and local support for US or EU handling studies
Clinical Development
  • Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
  • Identification and analysis of relevant clinical data
  • Clinical Investigations
tachysCP is a
software-product
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

Dr. Dirk KrederFounder and CEO

Dirk founded anteris medical together with Michael in 2014. He is a seasoned team leader of pharmaceutical and medical device development teams gone Entrepreneur.

Dirk has more than 15 years of experience in small and mid-size biotech…

Dr. Michael GschwandtnerCo-Founder and CTO

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…

Thierry Jomini, MBAGeneral Manager anteris helvetia AG

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…

Dr. Bernd KrämerSenior Director IVD

Bernd has more than 20 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…

Dr. Peter MüllerSenior Device Development Manager

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…

Johann Delchmann, B.Eng.Medical Device Specialist

Johann is a medical device specialist with experience in mid-size and global device and biotech organizations in the field development and project management for combination products and class IIa medical devices.

He has a special…

Maical Singh, B.Eng.Medical Device Specialist

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…

Dr. Eva SteierSenior Device Development Manager

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…

Vincent GuyotAssociated Director

Vincent is a biomedical engineer with more than 14 years’ experience in start-up and mid-sized medical device and pharma companies. He has led international projects in the field of design and tech transfer, for both class III medical…

Dr. Barbara GollobSenior Regulatory Expert Labeling and Combination Products

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 Harnisch, B.A.Marketing

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 LickovaConsultant and Project Manager

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 ZaborniakSenior Device Development Manager

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 KrasniqiConsultant and Project Manager

Monika is a specialist for design control of combination products and medical devices. She has gained experience during specific projects in university as a medical engineer in different fields, besides Biology and Physiology, also…

Fabricio KirchhoferConsultant and Project Manager

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 von RohrSenior Consultant and Project Manager

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 Abu-QaoudSenior Consultant and Project Manager

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 SchießlMedical Device Specialist

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 CachemailleSenior Human Factors Engineering Expert

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…

News

With 700 international participants from 25+ countries, MedFIT is a great opportunity to connect with international key innovators in the MedTech,…

Read more

‘Diagnostics-4-Future Conference‘ is the international meeting-place for users and providers from industry and science.

Based on questions in medical…

Read more

Due to coronavirus postponed to 8 - 10 June 2021.

T4M was initiated in 2019 and will open its doors in May 2020 for the second time. The exhibition…

Read more

Subscribe to our mailing list

* indicates required

Contact