Brazil Medical Device Regulations

On-Demand

Course Overview

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Brazil is utilizing MDSAP.

Additional Recommended Courses

MDSAP Internal Auditor Training

This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.

This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.

An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.

This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
  • Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
  • Recognize the competency and training requirements for AO auditors
  • Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
  • Calculate audit time and plan an MDSAP Lite internal audit
  • Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
  • Identify post-audit MDSAP activities including NC grading
  • Recognize the outcomes and goals of an MDSAP audit

Price: $1200.00

EU IVDR Internal Auditor

This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.

This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify Key Articles and Annexes of the EU IVDR
  • Recognize Intent of Requirements as Described in Recitals
  • Identify Classification Implementing and Classification Rules
  • Identify General Safety and Performance Requirements (GSPRs)
  • Recognize Content of Technical Documentation
  • Identify Post-Market Surveillance Reporting and Vigilance Obligations
  • Recognize one EU IVDR Audit Model
  • Plan an EU IVDR Audit
  • Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00

CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
  • Compose a proper and complete problem statement
  • Apply investigation techniques to identify root causes and define the appropriate corrective action
  • Identify effectiveness criteria and perform an effectiveness check
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.

Price: $1200.00