Using IEC62304 since the worldwide recognized software lifecycle standard the risk dependent activities and documentation needs will probably be described.
Simply how much detail is required inside the requirement specs?
Just what is a software unit?
How do integration testing be done without test harnesses? Will probably be clarified.
Practical guidance concerning how to make use of a streamlined but compliant development process will be provided.
Why can you attend: This web conferencing will highlight fundamental design control concepts as well as the criticality dependent needs for software development. Software specs, architectures and resulting design documentation will probably be discussed, additionally to practical easy methods to streamline the big event process and lower the regulatory burden.
Areas Covered inside the Session:
Software criticality classes
Software needs specs
Crafting significant needs
Multi software system implementation
Software design documentation
Software unit and integration testing
Software testing in solid-time systems
SOUP (software of unknown providence)
Project Management Software Software
Regulatory / Qc
Markus Weber, Principal Consultant with System Safety, Corporation., concentrates on safety engineering and risk management for critical medical devices. He finished Ruhr College in Bochum, Germany getting a MS in Electrical Engineering. Before founding System Safety, Corporation., he will be a software safety engineer for your German approval agency, TUV. Since 1991, Mr. Weber is really a leading consultant for the medical device industry on safety and regulatory compliance issues, designed for active and software-controlled devices. Using the Fda, he’s printed creates risk management issues and software-related risk mitigations. Mr. Weber helps multiple companies, from startups to Fortune 500 firms.
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
Tuesday, February 7, 2012
10:00 AM PST 01:00 PM EST
GlobalCompliancePanel is certainly a web-based training gateway delivering high quality regulatory & compliance trainings in the simple, economical plus an easy to function format.
GlobalCompliancePanel provides an array of channels for broadcasting and exchange of understanding through online training, web alerts & discussion forums.
GlobalCompliancePanel imparts knowledge of guidelines in industry to make sure effective implementation of compliance programs for meeting regulatory demands. The key factor focus of GlobalCompliancePanel is always to provide extensive and quality practicing risk management, regulatory compliances, corporate governance and quality management. Apart from offering excellent training to compliance professionals by compliance & speaking to experts, GlobalCompliancePanel would also focus on offering:
Information to make certain compliance and enhance quality with rules for individuals combined with the organizations
Latest updates on industry trends, industry guidelines and then for any alterations in the regulatory matters
One-stop place to go for your queries also to share and discuss issues, ideas and greatest practices and
An origin round the data sheets, whitepapers, articles, books on industry standards, training kits, software packages, insights, press bulletins, etc on governance, regulatory, compliances and quality management across different industries.
Publish Market Surveillance For Medical Devices Web conferencing By Globalcompliancepanel
New rules and rules are emerging inside the countries where the devices manufacturers market their items. The sheer quantity of rules and rules might be daunting, nevertheless the variations in each and every geographic market might be frightening. This web conferencing explains the areas of publish market surveillance that will assist you understand and set them into action.
The net seminar explains using publish-market surveillance a risk management file (ISO 14971) and updating your clinical evaluation (MDD Annex X). Furthermore, the net seminar compares and contrast the rules for adverse event reporting in the usa, EU, and Canada.
Why you ought to attend: Publish market surveillance might be complicated, but by breaking it lower into its parts, it might be accessible. While using understanding of the several components, you’ll be able to develop and implement a comprehensive system that will assist you stay in compliance. By attending this web conferencing, you’ll uncover what you should do and be well to be able to effective performance.
Areas Covered Inside the Session:
The Dwelling of Publish Market Surveillance
Medical Device Reports
Corrections and Removals
Complaints (ISO 13485)
EU FSCA and FSN
Canada Adverse Event Reporting
Publish Production Information Collection
Risk Management (ISO 14971)
Clinical Evaluation (MDD Annex X)
Regulatory Matters Managers
Design Control Managers
Dan could be the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, dedicated to analytic skills plus a systems approach to operations management. Dan has more than thirty years experience with quality, operations, and program management in controlled industries including aviation, defense, medical devices, and clinical labs. He’s a Masters Degree in Mathematics is certainly an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and 6 Sigma Black Belt which is certified by APICS in Resource Management.