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.

features and advantages

Meet the team

Dr. Dirk Kreder Founder and CEO LinkedIn Profile Download vCard
Dr. Michael Gschwandtner Co-Founder and CTO LinkedIn Profile Download vCard
Dr. Peter Müller Senior Device Development Manager LinkedIn Profile Download vCard
Johann Delchmann, B.Eng. Medical Device Specialist LinkedIn Profile Download vCard
Dr. Bernd Krämer Senior Director IVD LinkedIn Profile Download vCard
Dipl.-Ing. (FH) Andreas Harnisch Senior Device Development Manager LinkedIn Profile Download vCard
Dipl.-Ing. Manuel Kathofer Senior Device Documentation & Systems Specialist LinkedIn Profile Download vCard
Dr. Carola Seitz Marketing & Business Development LinkedIn Profile Download vCard
Dr. Thomas Brzoska Senior Clinical Evaluation Specialist LinkedIn Profile Download vCard
Mariella Schenk Operations & Human Resources Download vCard
Maical Singh, B.Eng. Medical Device Specialist Download vCard
Dr. Eva Steier Senior Device Development Manager Download vCard
Mirjam Steiner Contracts & Administration Download vCard
Dr. Barbara Gollob Senior Regulatory Expert Labeling and Combination Products LinkedIn Profile Download vCard
Dr. Christian Steinhauer Senior Device Development Manager LinkedIn Profile Download vCard
Nina Harnisch, B.A. Marketing LinkedIn Profile Download vCard

Read more about us

News

Dirk Kreder is invited as a speaker at the Drug/Device Combination Product Summit in December in Berlin!

His presentation takes place on Tuesday, 04...

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IVDR Transition Project - A Brief Guide

Read out our full article here.

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The new IVD regulation (IVDR) entered into force almost one and a half years ago. As the date of application for the IVDR is May 26th 2022, this means...

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