CTSafeย Center is in partnership with PECB to deliverย ISO courses in Vietnam. Professional Evaluation and Certification Boardย (PECB)ย is a global provider of training, examination, audit, and certification services for multiple fields.
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a โPECB Certified ISO 13485 Lead Implementerโ credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.ย
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles
The โPECB Certified ISO 13485 Lead Implementerโ exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competency domains:
Examination Features:
For specific information about exam type, languages available, and other details, please visit theย List of PECB Examsย and theย Examination Rules and Policies.
After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to theย Certification Rules and Policies.
The requirements for PECB Implementer Certifications are:
Credential
Exam
Professional experience
MDQMMS project experience
Other requirements
PECB Certified ISO 13485 Provisional Implementer
PECB Certified ISO 13483 Lead Implementer Exam or equivalent
None
Signing the PECB Code of Ethics
PECB Certified ISO 13485 Implementer
Two Years: One year of work experience in Medical Devices Quality Management
Project activities: a total of 200 hours
PECB Certified ISO 13485 Lead Implementer
Five Years: Two years of work experience in Medical Devices Quality Management
Project activities: a total of 300 hours
PECB Certified ISO 13485 Senior Lead Implementer
Ten Years: Seven years of work experience in Medical Devices Quality Management
Project activities: a total of 1,000 hours
ย Note:ย PECBย Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respectiveย PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link:ย https://pecb.com/en/master-credentials.ย
To be considered valid, these implementation activities should follow best implementation practices and include the following activities:
Students have 30 days to take a course in self-study method.
Distinguished 24 years career as an occupational health and safety security and environment (OHSSE) professional in heavy industrial settings, Binh Pham has demonstrated accuracy in dealing with hazardous work practices and conditions. He is competent in providing OHSSE consultations for functional departments and businesses and in providing regulatory compliance and site HSE audits and risk assessments. Binh strives to ensure businesses to develop and maintain a zero-injury safety culture through employees and contractors safety, health and environment training. He has provided loss prevention and risk management consulting parts to a variety of oil and gas, power, manufacturing, construction, and retail/distribution with a track record of satisfying results without Lost Time Injury (LTI) thorough his career.