Senior Device Development Manager

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

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. Sarah LongwitzSenior Consultant

Sarah joined anteris helvetia in April 2019 as Senior Consultant after 12 years in the medical device industry. She has extensive experience in leading device development projects and also in managing existing device platforms. She…

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 projects from idea phase to commercialization with international reach.

He has more than 10 years of experience in mid-size and global medical device and pharma companies and an…

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 3 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…

Dipl.-Ing. Manuel KathoferSenior Device Documentation & Systems Specialist

Manuel is a life sciences and IT Professional with 25 years’ experience in medical device and pharma organizations as well as in IT companies in the fields of quality management, compliance and risk management, software and hardware…

Dr. Thomas BrzoskaSenior Clinical Evaluation Specialist

Thomas is a clinical evaluation expert (+60 clinical and biological evaluations).

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,…

Dr. Christian SteinhauerSenior Device Development Manager

Christian is an instrument development expert with 10 years’ experience in development of complex instruments for research, laboratory and diagnostic applications.

He has a broad scientific and engineering background with the…

Mariella SchenkOperations & Human Resources

Mariella joined the anteris team in January of 2016 to support the growing demand in personal staffing and travel organization. Mariella's Teaching Degree plus Bachelor of Science in Tourism followed by 10 years of team management and…

Dr. Carola SeitzMarketing & Business Development

Carola joined the anteris team in the beginning of 2017 to provide support in the areas of marketing and business development.

When studying biology, Carola discovered here fascination with microbial fermentation processes and their…

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…

Mirjam SteinerContracts & Administration

Mirjam joined the anteris team to provide support in the area of contracts and administration. Mirjam has collected about 10 years of experience in an international CRO e.g. support on project management, study start up and contracts…

Natalia AlbrechtFinance, Controlling, and Accounting

Natalia supports us in the areas of Finance, Controlling, and Accounting.

At the beginning of her career she concentrated on training and further education in the banking sector and became a bank clerk with further education to a…

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