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.
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
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
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
Dipl.-Ing. Manuel Kathofer
Senior Device Documentation & Systems Specialist
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Dr. Barbara Gollob
Senior Regulatory Expert Labeling and Combination Products
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