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…

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…

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…

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. 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…

Dr. Thomas BrzoskaSenior Clinical Evaluation Specialist

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

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…

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…

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…

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…

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…

News

EMA position on new regulatory requirements for Medicinal Products with device constituent part

Klick HERE to read our full article.

Read more

With the revision of the regulatory framework for medical devices in Europe, the Medical Device Regulation (MDR) is also introducing new requirements

Read more

The injection device market is moving quickly, and operating in this market is exciting. All the challenges of device and combination product…

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