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Anteris Medical GmbH

Holzkirchen, DE

We support our customers in their medical device challenges during development, through registration and beyond

Success results from connection - connection of ideas, connection of expertise and connection of experience. Anteris medical has been founded in 2014 and supports the pharmaceutical, biotech and medical device industries globally by managing the development of combination products, medical device products or in vitro diagnostics. Our broad competencies cover compliance, regulatory affairs combined with innovative, resource-efficient solutions for compliant development and technical documentation as well as marketing and sales expertise. We are life sciences and engineering majors with dozens of years of experience in CE marking, 510(k) submissions, and quality systems regulations in all major markets. Let's connect!

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Medical Device Development
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Clinical Development Strategy
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  • Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
  • Identification and analysis of relevant clinical data
  • Clinical Investigations
  • Creation of clinical evaluation according to MEDDEV. 2.7.1 by qualified individuals
  • Identification and analysis of relevant clinical data
  • Clinical Investigations
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Toxicology Risk Assessment
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  • Implementation of risk management processes according to ISO 14971
  • Moderation of risk management meetings
  • Implementation of risk management processes according to ISO 14971
  • Moderation of risk management meetings
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Medical Device Development Consulting
Price on request

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... Show more »

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

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Project and Process Management
Price on request

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

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

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Clinical Research
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Clinical Trials, Consulting, and Management
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Pharmacology & Toxicology
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Toxicology
Price on request
Request a quote for more information about this service.
Medical Devices & Diagnostics
Price on request
Request a quote for more information about this service.

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