Masterclass on RAC (Devices) Preparation Strategy on 24th April
We have several courses that can be conducted live, either on-site or online depending on your requirements.
Course development:
These courses are developed by subject matter experts with decades of experience in the medical device industry and include their personal insights. Some have previously provided similar courses for other trainers that ensures their quality and rigour.
Evaluation:
Learners are continuously evaluated through engagements and quizzes. ML testing is reinforced by real-life case studies. At the course programme closure, a certificate is awarded by Neulearn.
The trainers:
Each course is conducted by one or more qualified trainers. These trainers have practical experience of having worked in the medical devices and are likewise regulatory approved trainers for courses.
Course duration:
The training time quoted therefore for each course is listed. However, the duration can be shortened or extended by customising the course as per need of the learners.
Certificate:
At the completion of each assignment accredited courses are offered with a CPD accredited certificate that adds value to learners’ professional experience.
Please contact us via email or phone, or submit the enquiry form with your requirements.
Available Training Courses
CPC Accreditation
Accredited
Duration: 2 Days
Objectives & Topics
- Understand and apply the QMS principles behind the Standard
- Structure and intent of the Standard
- Implement & maintain the requirements of the Standard
CPC Accreditation
Accredited
Duration: 2 Days
Objectives & Topics
- Understand the process of risk management from hazard identification to risk control
- Risk analysis, evaluation and control
- Managing residual risks
- Benefit Risk Analysis
- How to form a team and align everyone
CPC Accreditation
In Progress
Duration: 2 Days
Objectives & Topics
- Framework of the regulation
- The Actors and Regulatory Entities
- The Essential Principles (GSPR)
- Classification Rules
- Eudamed and UDI
- Labelling
- Clinical Evaluations and Investigations
- QMS
- Technical Documentation
CPC Accreditation
In Progress
Duration: 2 Days
Objectives & Topics
- Framework of the regulation
- The Actors and Regulatory Entities
- The Essential Principles (GSPR)
- Classification Rules
- Eudamed and UDI
- Labelling
- Clinical Evaluations and Investigations
- QMS
- Technical Documentation
CPC Accreditation
Accredited
Duration: 2 Days
Objectives & Topics
- The framework of the Regulation
- Role of the CDSCO and Notified Bodies
- The Licensing process
- The Essential Principles
- Classification Rules
- QMS
- Labelling and UDI
- Clinical Evaluations & Investigation
- Technical Documentation
- PMS
CPC Accreditation
Accredited
Duration: 1 Days
Objectives & Topics
- Audit and its purpose
- The skills and competencies required
- Verbal and non-verbal communication
- The power of observation
- Audit Planning – from research to the plan
- Audit execution
- Writing audit observations correctly
- Audit closure