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Remediate. Medical Engineering. Radically.

Services

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Benefit/Risk Analysis

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Risk 

Management

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Pre- and Post-Market Surveillance

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Manufacturing

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Regulatory Compliance

Our Promise
for Your Business
Continuity

Here in Switzerland, we believe in precision, effectiveness and efficiency. That is why we set up a toolbox that allows you to have highly efficient, precisely coordinated processes. Based on your current process landscape, we develop a plan for the implementation and improvement of existing process interfaces that fit your company. At Remedical, we take a rigorous practical approach to execution. In previous projects we have successfully proven that we can reduce the workload by up to 70% by using fully integrated processes that work hand in hand. Don't waste resources on what's supposed to work silently in the background - just like a Swiss clockwork.

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Medical Device
Risk Management

One if not the core process in our medical device Industry is an effective Risk Management process. A TUV lead auditor we know once called it "the beating heart of any medical device company" and we couldn´t agree more. Patient, user and environment safety should be highest priority anyway but having a fully implemented Risk Management process serves more purposes. Beyond improving your design and development activities resulting in better performing products, leading to fully satisfied patients and users, it furthermore reduces redundant work and missing guidance throughout the entire life cycle management. This improves your company image, credibility, and contractor relationships.

Medical device development should be Risk-based Engineering to serve your patients and customers, so they can enjoy an improved quality of life and safer medical devices.

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Focus

  • Consulting, Automation and Training

  • Risk Management

    • Product

    • Usability​

    • Design

    • Process

  • Design Control

  • Post Market Surveillance

  • ​Design Verification & Validation

  • Process Optimization and Remediation

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Specialized
Advisory
Services

Our services covers a broad spectrum of quality assurance and regulatory assurance activities governed by, but not limited to, the global regulations set by FDA CFR 21 Part 820, ISO 13485 and EU MDR 2017/745.

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Are you facing other challenges or seek specialized advisory services for your medical device business?

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Get in contact with us with and we will reply within a timely manner.

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