Medical Management Training and Courses

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Implementing ISO 13485:2016 - Training Courses

You'll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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ISO 13485:2016 Senior Management Briefing Training Courses

As a leader, your commitment and support is crucial to the success of your organization's ISO 13485:2016 Medical Devices Quality Management System (QMS). This interactive briefing has been designed around the requirements of the standard and highlights your responsibilities in terms of leadership and commitment. The focus is on helping senior management migrate their system from ISO 13485:2003 to ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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Transition and Auditor Refresher Course from 13485:2003 to 13485:2016 Training Courses

With greater attention on the organization's ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You'll refresh your auditing techniques and be able to ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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Understanding ISO 14971:2007 Training Courses

BSI's "Understanding ISO 14971:2007" course is designed to provide participantswithan understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971:2007 can improve their business and risk management efforts. Participants will also ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line

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Introduction to ISO 13485:2016 Training Courses

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA's Quality System Regulation. The relationship with ISO 14971 “Application of Risk Management to Medical Devices” is also explored during the course. ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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ISO 13485:2016 Auditor Refresher Training Courses

Are you an existing auditor with knowledge of ISO 13485 wishing to update your audit programme in line with ISO 13485:2016? This course will refresh your auditing techniques and help you prepare to audit against requirements. With a transition period of 3 years, it's important to get up to speed so you can ensure your organization is ready to comply with new requirements. Through audit scenarios, ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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BSI - ISO 13485 Quality Management System Software

Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose. The ISO 13485 standard is an effective solution to meet the ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA).

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IVD Directive to IVD Regulation Transition Training Course

There are significant changes in the European legislation applicable to IVDs. The IVD Regulation has replaced the IVD Directive, which will impose new requirements on manufacturers and other economic operators. By attending this course, you’ll discover the new requirements and how these will affect your organization. ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - CE Marking Training Training line

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ISO 13485:2016 Transition Training Courses

Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard. With greater attention on the organization's ability to meet applicable customer and regulatory requirements, ISO 13485:2016 focuses on the ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line

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Performance Evaluation and Clinical Evidence for IVDs Training Course

If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe, this intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line

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Medical Device Directive CE Marking

BSI's “Medical Devices CE Marking” three day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course. Participants will gain knowledge of the requirements of ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - CE Marking Training Training line

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ISO 14971 Medical Devices Risk Management Training Courses

This course is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line

Continuing Education

Important Update for California REHS. Beginning January 1, 2019, the National Environmental Health Association (NEHA) will no longer provide Certificates of Attendance (COA) for Continuing Education (CE.). COAs will be provided for CEs earned through December 31, 2018 using the existing request form. CEs earned on or after January 1, 2019 will not require COAs and requests will not be processed. ...

By National Environmental Health Association (NEHA) based in Denver, COLORADO (USA).

Epi-Ready Team Training: Foodborne Illness Response Strategies

Developed in partnership with the Centers for Disease Control and Prevention, Epi-Ready is a two-day in-person workshop for environmental and public health professionals with responsibility for investigation of foodborne illness outbreaks. With a team-based approach to training, Epi-Ready focuses on how to efficiently and effectively respond to an outbreak by understanding the roles and ...

By National Environmental Health Association (NEHA) based in Denver, COLORADO (USA).

Workforce Development Program

NEHA, through a funding agreement with the Association of State and Territorial Health Officials (ASTHO), is continuing to work with the Centers for Disease Control and Prevention/National Center for Environmental Health (CDC/NCEH) to support efforts already underway to build capacity and infrastructure of the overall public health system, and more specifically to support the goals outlined by ...

By National Environmental Health Association (NEHA) based in Denver, COLORADO (USA).

Training & Education

Designed and led by certified instructors who are also members of our customer support team, our training program blends flexible learning options with consistent standards to increase user proficiency and maximize your staff’s and your system’s performance. From basic operator training through advanced diagnostics and maintenance, we provide a full-circle approach for every staff ...

By Ortho Clinical Diagnostics based in Raritan, NEW JERSEY (USA).

Implementing Robust Supply Chains

This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines. Implementing Robust Supply chains for life-sciences companies are important now and growing in importance as device manufacturers outsource products and services low cost destinations it ...

By ComplianceOnline based in Palo Alto, CALIFORNIA (USA). from Trade and Logistics Training line

EU Medical Device Regulations - Comprehensive Compliance Training Course

Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification ...

By ComplianceOnline based in Palo Alto, CALIFORNIA (USA). from Medical Devices Training line

Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (5 Courses)

This comprehensive training package is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing regulations. This comprehensive training package is aimed at helping medical device companies ensure that their As manufacturing becomes increasingly global, with responsibility for various parts of the final product vesting with ...

By ComplianceOnline based in Palo Alto, CALIFORNIA (USA). from Medical Devices Training line

Risk-Based Validation Courses

This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities. A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. The cost and time savings associated with using risk-based validation will be presented. Over ...

By GlobalCompliancePanel based in Fremont, CALIFORNIA (USA).