93/ 42/ EEC Medical Device Regulations are determined by European Union Committee and all the medical device producers have to follow these regulations. 93/ 42/ EEC Medical Device Regulations expects to have the performance and safety parameters (biocompatibility, biomechanics, sterility, shelf life and compatibility with the required standards) of the product and the strategies that will be used to achieve these parameters determined and to prove that the product is compatible with these parameters. All the work done in order to prove that the device is compatible with the regulations is gathered together to form the technical file. After it is proved that the device meets all the 93/ 42/ EEC Medical Device Regulations, the product can be marked with CE marking. If the product is listed under low risk category, the Declaration of Conformity should be enough to have the product sold in the medical device market. Products that are listed under medium and high risk groups must be audited and approved by a notified body. After getting approved by the notified body, medical device producer deserves the right to get its CE Certificate.
This is a process that requires knowledge about the standards and regulations. Getting the Medical Device CE Certification Consulting during this process will help you to,
Get your CE Certificate in optimum time period,
Improve your staff’s knowledge about the standards, regulations and quality controls,
Understand and apply the 93/ 42/ EEC Medical Device Regulations easily and efficiently
Stay away from unnecessary spending.
TıbbiCE Consulting, Training and Validation Services, offers consulting, training and validation services to domestic and overseas medical device producers during their CE and ISO 13485 Certification (93/42/EEC) process. With its expert staff from different backgrounds including but not limited to biology and biomedical, mechanical and metallurgy engineering, TıbbiCE Consulting, Training and Validation Services is the medical device consulting company with the largest expert staff in Turkey.
TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.
What is validation?
Which processes must be validated?
Ethylene Oxide Sterilization Validation
It is the process of verifying the ethylene oxide sterilization process and ensuring that its routine controls are done with respect to the requirements of ISO 11135 and ISO 14937 standards. At this point, the questions such as what will be the gas concentration and the duration of the sterilization and how long the product should be ventilated must be answered.
Vapor Autoclave Sterilization Validation
It is the process of verifying the vapor autoclave sterilization process and ensuring that its routine controls are done with respect to the requirements of ISO 17665-1 standard. At this point, the questions such as at what temperature and for how long the sterilization will be done must be answered.
Gamma Sterilization Validation
It is the process of verifying the gamma sterilization process and ensuring that its routine controls are done with respect to the requirements of ISO 11137 standard. At this point, the questions such as what will be the percentage of the gamma ray during sterilization must be answered.
Packaging Validation
Ultrasonic Cleaning Validation
Medical products must be cleaned before the final packaging process. The residuals left from the production and cleaning processes must be removed from the metal and plastic medical devices.
One of the techniques used in this step is ultrasonic cleaning. Ultrasonic cleaning must be done under controlled conditions and the process must be validated.
The effectiveness of this process must be validated by;
Determining the contamination ratio of the product
Cleaning the product under controlled conditions
Not having any contaminating or cleaning agents after the cleaning process.
As TıbbiCE Consulting, Training and Validation Services, we have been giving consulting, training and validation services to medical device producers for more than 6 years. Until now, our firm has worked with more than 60 medical device producers and involved in the CE certification process of more than 300 medical devices.
TıbbiCE Consulting, Training and Validation Services, offers consulting, training and validation services to domestic and overseas medical device producers during their CE and ISO 13485 Certification (93/42/EEC) process. With its expert staff from different backgrounds including but not limited to biology and biomedical, mechanical and metallurgy engineering, TıbbiCE Consulting, Training and Validation Services is the medical device consulting company with the largest expert staff in Turkey.
TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.