Emergo offers several on-site training classes for medical device manufacturers focusing on a variety of quality assurance topics and regulatory aspects such as submissions or compliance.
CE Marking Training
Covers the steps to CE Marking and Medical Devices Directive compliance, how to compile a Technical File, requirement of a risk assessment, selecting a Notified Body, plus prepare a Declaration of Conformity and more.
ISO 13485 Training
This training provides an overview of the ISO 13485:2003 standard along with a discussion of how to set quality objectives, define responsibility, create a quality policy manual, implement quality system procedures, and other topics.
FDA QSR Training (21 CFR Part 820)
Provides an overview of the US FDA and the Quality System Regulations plus specific discussions about conducting internal audits, evaluating suppliers, process validations, creating corrective actions and many other topics.
Internal Auditor Training
Discusses the responsibilities of management, measuring and evaluating organizational performance, requirements for incident reporting, risk analysis and overall compliance with ISO 13485, FDA GMP, CE Marking, and Canadian Medical Device Regulations (CMDR).
ISO 14971 Risk Management Training
Covers the ISO 14971 standard as it applies to medical device companies including regulatory and reporting requirements plus development of processes to better control risks.
Medical Device UDI (Unique Device Identification) Consulting and Training
Unique Device Identification (UDI) requirements for medical devices are currently being implemented by the US Food and Drug Administration, and other market regulators will launch similar programs in the coming months and years. Covers training to educate your staff on proper UDI compliance and training on how to incorporate UDI processes into your quality management and production operations.