During COVID 19 Pandemic, we offer remote in house training courses. Like onsite ones, these aim that everyone leaves the course with required knowledge for regulatory compliance. As many medical device manufacturers experience in daily life, regulations in many countries show increasing complexity and require a high level regulatory knowledge.
MEDLOFT offers in house training courses to improve staff knowledge, competency and bring quality and regulatory skills to the desired level. Knowing that for medical device manufacturers providing internal training is often difficult, MEDLOFT experts with wide range of experience in their own areas, provide you high-quality content. Compared to many other training contents, these courses are designed to give practical knowledge through interesting workshops and meaningful learning tasks parallel to the theory.
Which in house training is needed to ensure conformity of your QMS and compliance of your Medical Device?
During the planning stage our experts review your product portfolio, applicable standards, and regulation with your key personnel. During a meeting they discuss with you strong and week areas in your processes and recommend applicable training modules.
A few examples can be listed as;
- Implementation of ISO 13485 QMS
- FDA 510 K submission requirements
- Technical documentation according to EU MDR
- Design Control Process
- Clinical Evaluation Process
- Post Marketing Surveillance Process
- Risk Management Process according to ISO 14971
All training modules have a flexible content, which bring two main advantages to you. Firstly, they can be easily adapted to your company needs. Secondly the duration of the modules can be optimized for remote training option.
Who shall attend the in-house training?
Our dedicated expert reviews your key product realization processes and define with your department responsible the candidate trainees. For on-site trainings up to 20 trainees will ensure the effectiveness of the training, whereas for remote in house trainings we recommend max 10 trainees.
After defining the exact training content and staff, we define the optimum date and run the training.
Evaluation of the training effectiveness?
Once training is completed, often the effectiveness evaluation method required as per ISO 13485 clause 6.2.c can be a challenge for medical device manufacturers. Our experts will be more than happy to help you by implementing our effective evaluation tools. According to the type and nature of the training this can be a short quiz, detailed exam or evaluation of the trainee performance during a specific workshop.
Our tailor-made in-house training courses can be designed according to your product portfolio and staff competency. Contact our experts to start discussing the details of your course.