(IRR) ﷼
United Arab Emirates dirham(د.إ)
Afghan afghani(؋)
Albanian lek(L)
Armenian dram(AMD)
Netherlands Antillean guilder(ƒ)
Angolan kwanza(Kz)
Argentine peso($)
Australian dollar($)
Aruban florin(Afl.)
Azerbaijani manat(₼)
Bosnia and Herzegovina convertible mark(KM)
Barbadian dollar($)
Bangladeshi taka(৳ )
Bulgarian lev(лв.)
Bahraini dinar(.د.ب)
Burundian franc(Fr)
Bermudian dollar($)
Brunei dollar($)
Bolivian boliviano(Bs.)
Brazilian real(R$)
Bahamian dollar($)
Bitcoin(฿)
Bhutanese ngultrum(Nu.)
Botswana pula(P)
Belarusian ruble (old)(Br)
Belarusian ruble(Br)
Belize dollar($)
Canadian dollar($)
Congolese franc(Fr)
Swiss franc(CHF)
Chilean peso($)
Chinese yuan(¥)
Colombian peso($)
Costa Rican colón(₡)
Cuban convertible peso($)
Cuban peso($)
Cape Verdean escudo($)
Czech koruna(Kč)
Djiboutian franc(Fr)
Danish krone(kr.)
Dominican peso(RD$)
Algerian dinar(د.ج)
Egyptian pound(EGP)
Eritrean nakfa(Nfk)
Ethiopian birr(Br)
Euro(€)
Fijian dollar($)
Falkland Islands pound(£)
Pound sterling(£)
Georgian lari(₾)
Guernsey pound(£)
Ghana cedi(₵)
Gibraltar pound(£)
Gambian dalasi(D)
Guinean franc(Fr)
Guatemalan quetzal(Q)
Guyanese dollar($)
Hong Kong dollar($)
Honduran lempira(L)
Croatian kuna(kn)
Haitian gourde(G)
Hungarian forint(Ft)
Indonesian rupiah(Rp)
Israeli new shekel(₪)
Manx pound(£)
Indian rupee(₹)
Iraqi dinar(د.ع)
Iranian rial(﷼)
Iranian toman(تومان)
Icelandic króna(kr.)
Jersey pound(£)
Jamaican dollar($)
Jordanian dinar(د.ا)
Japanese yen(¥)
Kenyan shilling(KSh)
Kyrgyzstani som(сом)
Cambodian riel(៛)
Comorian franc(Fr)
North Korean won(₩)
South Korean won(₩)
Kuwaiti dinar(د.ك)
Cayman Islands dollar($)
Kazakhstani tenge(₸)
Lao kip(₭)
Lebanese pound(ل.ل)
Sri Lankan rupee(රු)
Liberian dollar($)
Lesotho loti(L)
Libyan dinar(د.ل)
Moroccan dirham(د.م.)
Moldovan leu(MDL)
Malagasy ariary(Ar)
Macedonian denar(ден)
Burmese kyat(Ks)
Mongolian tögrög(₮)
Macanese pataca(P)
Mauritanian ouguiya(UM)
Mauritian rupee(₨)
Maldivian rufiyaa(.ރ)
Malawian kwacha(MK)
Mexican peso($)
Malaysian ringgit(RM)
Mozambican metical(MT)
Namibian dollar(N$)
Nigerian naira(₦)
Nicaraguan córdoba(C$)
Norwegian krone(kr)
Nepalese rupee(₨)
New Zealand dollar($)
Omani rial(ر.ع.)
Panamanian balboa(B/.)
Sol(S/)
Papua New Guinean kina(K)
Philippine peso(₱)
Pakistani rupee(₨)
Polish złoty(zł)
Transnistrian ruble(р.)
Paraguayan guaraní(₲)
Qatari riyal(ر.ق)
Romanian leu(lei)
Serbian dinar(рсд)
Russian ruble(₽)
Rwandan franc(Fr)
Saudi riyal(ر.س)
Solomon Islands dollar($)
Seychellois rupee(₨)
Sudanese pound(ج.س.)
Swedish krona(kr)
Singapore dollar($)
Saint Helena pound(£)
Sierra Leonean leone(Le)
Somali shilling(Sh)
Surinamese dollar($)
South Sudanese pound(£)
São Tomé and Príncipe dobra(Db)
Syrian pound(ل.س)
Swazi lilangeni(E)
Thai baht(฿)
Tajikistani somoni(ЅМ)
Turkmenistan manat(m)
Tunisian dinar(د.ت)
Tongan paʻanga(T$)
Turkish lira(₺)
Trinidad and Tobago dollar($)
New Taiwan dollar(NT$)
Tanzanian shilling(Sh)
Ukrainian hryvnia(₴)
Ugandan shilling(UGX)
United States (US) dollar($)
Uruguayan peso($)
Uzbekistani som(UZS)
Venezuelan bolívar (2008–2018)(Bs F)
Venezuelan bolívar(Bs.)
Vietnamese đồng(₫)
Vanuatu vatu(Vt)
Samoan tālā(T)
Central African CFA franc(CFA)
East Caribbean dollar($)
West African CFA franc(CFA)
CFP franc(XPF)
Yemeni rial(﷼)
South African rand(R)
Zambian kwacha(ZK)
Litecoin(LTC)
Ethereum(ETH)
Zimbabwe Dollar(ZWD)
Zimbabwe(ZWL)
+1 (780)-800- 8357
7445 Roper Rd NW, Edmonton, AB T6B 3K9, Canada
Course
Book Appoinment
FAQ
Contact Title
Let's Talk +1 (780)-800- 8357
contact us
Contact Title
Let's Talk +1 (780)-800- 8357
contact us
page-banner-shape-1
page-banner-shape-2

Category: ISO 13485

Sale!
Categories:

PECB Certified ISO 13485 Lead Implementer – Training Course

Why should you attend?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 “PECB Certified ISO 13485 Lead Implementer” 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.Who should attend?
  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members
Learning objectives
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
  • This training is based on both theory and best practices used in the implementation of a MDQMS
  • Lecture sessions are illustrated with examples based on case studies
  • Practical exercises are based on a case study which includes role playing and discussions
  • Practice tests are similar to the Certification Exam
PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Day 1: Introduction to ISO 13485 and initiation of a MDQMSDay 2: Plan the implementation of a MDQMSDay 3: Implementation of a MDQMSDay 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification auditDay 5: Certification Exam
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 the Certification Rules and Policies.The requirements for PECB Implementer Certifications are:
CredentialExamProfessional experienceMDQMMS project experienceOther requirements
PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentNoneNoneSigning the PECB Code of Ethics
PECB Certified ISO 13485 ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTwo Years: One year of work experience in Medical Devices Quality ManagementProject activities: a total of 200 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentFive Years: Two years of work experience in Medical Devices Quality ManagementProject activities: a total of 300 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTen Years: Seven years of work experience in Medical Devices Quality ManagementProject activities: a total of 1,000 hoursSigning the PECB Code of Ethics
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective 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: https://pecb.com/en/master-credentials.To be considered valid, these implementation activities should follow best implementation practices and include the following activities:Drafting a MDQMS planInitiating a MDQMS implementationImplementing a MDQMSMonitoring and managing a MDQMS implementation
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certification and examination fees are included in the price of the training course
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Why should you attend?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 “PECB Certified ISO 13485 Lead Implementer” 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.Who should attend?
  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members
Learning objectives
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
  • This training is based on both theory and best practices used in the implementation of a MDQMS
  • Lecture sessions are illustrated with examples based on case studies
  • Practical exercises are based on a case study which includes role playing and discussions
  • Practice tests are similar to the Certification Exam
PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Day 1: Introduction to ISO 13485 and initiation of a MDQMSDay 2: Plan the implementation of a MDQMSDay 3: Implementation of a MDQMSDay 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification auditDay 5: Certification Exam
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 the Certification Rules and Policies.The requirements for PECB Implementer Certifications are:
CredentialExamProfessional experienceMDQMMS project experienceOther requirements
PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentNoneNoneSigning the PECB Code of Ethics
PECB Certified ISO 13485 ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTwo Years: One year of work experience in Medical Devices Quality ManagementProject activities: a total of 200 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentFive Years: Two years of work experience in Medical Devices Quality ManagementProject activities: a total of 300 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTen Years: Seven years of work experience in Medical Devices Quality ManagementProject activities: a total of 1,000 hoursSigning the PECB Code of Ethics
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective 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: https://pecb.com/en/master-credentials.To be considered valid, these implementation activities should follow best implementation practices and include the following activities:Drafting a MDQMS planInitiating a MDQMS implementationImplementing a MDQMSMonitoring and managing a MDQMS implementation
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certification and examination fees are included in the price of the training course
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
﷼34,465,899.22 ﷼67,491,969.75Price range: ﷼34,465,899.22 through ﷼67,491,969.75
Enroll Now
Sale!
Categories:

PECB Certified ISO 13485 Foundation – Training Course

Why should you attend?ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.After completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.Who should attend?
  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • Individuals interested to pursue a career in Medical Devices Quality Management
Learning objectives
  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS
Educational approach
  • Lecture sessions are illustrated with practical questions and examples
  • Practical exercises include examples and discussions
  • Practice tests are similar to the Certificate Exam
PrerequisitesNone
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485Day 2: Medical Devices Quality Management System requirements and Certificate Exam
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)Domain 2: Medical Devices Quality Management System (MDQMS)For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certificate and examination fees are included in the price of the training course
  • Training material containing over 200 pages of information and practical examples will be distributed
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Why should you attend?ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.After completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.Who should attend?
  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • Individuals interested to pursue a career in Medical Devices Quality Management
Learning objectives
  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS
Educational approach
  • Lecture sessions are illustrated with practical questions and examples
  • Practical exercises include examples and discussions
  • Practice tests are similar to the Certificate Exam
PrerequisitesNone
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485Day 2: Medical Devices Quality Management System requirements and Certificate Exam
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)Domain 2: Medical Devices Quality Management System (MDQMS)For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certificate and examination fees are included in the price of the training course
  • Training material containing over 200 pages of information and practical examples will be distributed
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
﷼22,497,323.25 ﷼46,494,468.05Price range: ﷼22,497,323.25 through ﷼46,494,468.05
Enroll Now