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ISO 14155:2020

Clinical Investigation of Medical Devices Management

Safe research... reliable results... responsible innovation

Guideline Clinical Research Healthcare
1

Standard Definition

Overview of ISO 14155:2020

ISO 14155:2020 is your comprehensive guide for conducting clinical investigations of medical devices with the highest safety and quality standards, ensuring participant protection, result reliability, and compliance with global ethical and regulatory standards.
2

Standard Importance

Why is this standard important?

Because medical device development requires investments up to $94 million, and 90% of devices fail in clinical trials due to poor planning. Standard implementation achieves: 75% increase in trial success, reduced costs and time, safety assurance, regulatory compliance.
3

Implementation Benefits

Advantages your organization will gain

75% increase in clinical trial success, reduced required costs and time, participant safety assurance, regulatory standards compliance, improved data quality, accelerated regulatory approvals, increased investor and partner confidence
4

Target Organizations

Who can implement this standard?

Vital for all medical device development participants: medical device companies, medical research centers, university hospitals, contract research organizations, regulatory bodies, clinical trial centers.
5

Implementation Scope

How is the standard implemented within the organization?

The standard covers all clinical trial phases: planning and design, participant selection, conducting trials, data collection, statistical analysis, risk management, monitoring and follow-up, documentation and reporting, ethical compliance.
6

Assdaf Methodology

How we help you qualify and obtain certification

At Assdaf, we believe that medical research is an ethical responsibility before being a commercial opportunity. Our methodology includes: designing robust protocols, implementing highest safety standards, training specialized teams, strict quality monitoring, ensuring ethical compliance.
7

Certification Benefits

Additional advantages of obtaining certified accreditation

Assdaf your partner in transforming medical ideas into safe life-saving solutions. We guarantee conducting clinical trials that achieve your scientific and commercial goals with complete safety. Reliable research, guaranteed results, responsible innovation.

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Standard Information
Standard Code ISO 14155:2020
Category Medical & Healthcare Sector Systems
Version 2020
Type Guideline
Family Clinical Research
Sector Healthcare
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