On-Site Regulatory Training for Medical Device Companies
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. We do not offer public training classes. We tailor our training sessions to the needs of your employees and conduct it at your facilty. We charge one fixed price for training, regardless of whether you want 3 or 30 employees trained. This makes it an excellent value for companies that need to train employees on changes to ISO 13485:2016, the new European Medical Device Regulations (MDR), risk management, QSR compliance or how to conduct internal audits.
CE Marking Training
Covers the steps to CE Marking and MDD/MDR compliance, Technical File compilation, risk assessment, Clinical Evalution, PMS, selecting a Notified Body, and more.
ISO 13485:2016 Training
This training provides an overview of the ISO 13485:2016 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 QSR, CE Marking, and Canadian Medical Device Regulations (CMDR).
ISO 14971:2012 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.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.