Over the years, ZOOP technical team has kept up with the update of medical device regulations and standards, and actively participated in high-standard discussions on new standards and regulations.With nearly 10 years of practical experience in registration,as well as the strength of the internal and external senior experts,ZOOP can provide specialized training services related to medical devices, and provide definitely help for enterprises to solve problems and improve special projects!
Services are available as follows：
1.Relevant training on design and development
Training on the design and development process.
Training on technical materials of medical devices.
Impact of regulations and special requirements on product design.
2.Relevant training on risk management
Training on risk management for medical devices.
Hazard classification and risk mechanism.
Risk assessment and acceptance limits.
Hazardous situation and risk control measures.
Absolute risk and relative risk.
Risk monitoring during and after production.
Risk identification of IVD devices and control measures that not mentioned in the standard.
3.Training on ISO13485 Standard
Training on YY/T 0287 idt ISO 13485 standard
Training on ISO 13485：2016 standard
Training on internal auditor for ISO 13485：2016 new standard
4. Counseling Service for Production System
We provide professional consulting services on plant facilities, research and development processes, regulatory training, standard writing, risk management, measurement systems , etc., for start-up medical device manufacturers,production transformation enterprises or enterprises preparing for new product listing.
The counseling is based on regulations,deeply analyzes the requirements, product classification, management status and sales channels of production enterprises, by virtue of the deep understanding of regulations and standards, to guide and assist companies in responding to on-site supervision and inspection by drug regulatory authorities at all levels.