CERTIFICATION IN INDIA

ISO 14155 - GOOD CLINICAL PRACTICES

What is ISO 14155?

The International Organization for Standardization (ISO) publishes the ISO standard for Good clinical practices (GCP) for the design, conduct, recording, and reporting of clinical studies with medical devices.

Conducting your clinical studies according to GCP is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and rest of the world.

The EU Medical Devices Regulation (MDR) 2017/745 requires clinical investigations to be conducted according to GCP and directly references the ISO14155 standard. The US Food and Drug Administration (FDA) accepts clinical data collected outside the US for market applications under the condition that GCP has been followed. FDA recognizes the ISO 14155 standard for medical device trials. Other regions similarly recognize the GCP standard.

Benefits of ISO 14155 Certification

Leading to Better

Actionable Data

Product Quality

Improves customer confidence

Insight into your Supply Chain

Safety Assurance

Who can be certified ISO 14155 Certification?

Shamkris Group

Injection

Shamkris Group

Testing Kits

Shamkris Group

Medical Furniture

Shamkris Group

Medical Equipment

Shamkris Group

IVD Instruments

Shamkris Group

Surgical Instruments

Shamkris Group

Dental Implants

Shamkris Group

Ortho Implants

Shamkris Group

Disposable Syringes Needles

Document required for ISO 14155 Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of ISO 14155 Certification

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.

The implementation process is described below:

Time Frame

Task

Process

Day 1

GAP Analysis
Certification Body
Selection
Cost Estimates

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Certification Body
Audit
N-C Closing

Week 12

Certification Body

Year on Year

Yearly Compliance

FAQ

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
 
The second revision of the standard was released in February 2011, the third revision and therefore current version of the standard was released in July 2020, ISO 14155:2020.