Your aim as a manufacturer of IVD medical devices is a quick development process resulting in a shorter time-to-market. Timely planning of required testing gives you the decisive time advantage and reduces development costs.The validation of software and production processes, including the validation of software used in these processes, is an essential and critical element for the safety and operability of your IVD medical device. Do you really know the ropes?The prerequisite for planning verification and validation are risk analysis and the specifications. What is the intended use? Who are the users? Just two important questions!We are your experienced partner when it comes to verification and validation of in vitro diagnostic medical devices. Let’s get in touch!
DIN EN ISO 9000:2015-11
Verification is the confirmation, through provision of objective evidence, that specified requirements have been fulfilled.”
Validation is the confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.”
Validation is the confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.”
The verification process at a glance
Verification: how we help you reduce your development costs and time-to-market
Reduce development costs and time-to-market
- Verification planning based on specifications and risk analysis,
- Defining the test specification,
- Performing and analyzing verification,
- Drawing up the verification report,
- Validating (planning, performing, reporting) the IVD medical device.
Verification may quickly become time and cost-intensive. By means of a strategic coordination of Development and Regulatory Affairs we realize the ideal solution.
Contact usVerification and validation: Definition according to DIN EN ISO 13485-2016
7.3.6 Design and development verificationDesign and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements. The organization shall document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size. If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification shall include confirmation that the design outputs meet design inputs when so connected or interfaced. Records of the results and conclusions of the verification and necessary actions shall be maintained.7.3.7 Development validationDesign and development validation shall be performed in accordance with planned and documented processes to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size. Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded (see4.2.5). As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements. A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer. If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification shall include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced. Validation shall be completed prior to release for use of the product to the customer. Records of the results and conclusions of the validation and necessary actions shall be maintained (see 4.2.4 and 4.2.5).
How are you organized?
Do you have the terms verification and validation defined within your company? What is your approach in this regard? Is verification/validation carried out by an independent team? Is the evidence objective? Not to forget: Do you define the acceptance criteria in advance? Do you describe the statistical techniques with rationale for sample size? And then, in addition to product validation, processes, methods and software must also be validated among others.
If you have any questions: We have the answers.
Do you have the terms verification and validation defined within your company? What is your approach in this regard? Is verification/validation carried out by an independent team? Is the evidence objective? Not to forget: Do you define the acceptance criteria in advance? Do you describe the statistical techniques with rationale for sample size? And then, in addition to product validation, processes, methods and software must also be validated among others.
If you have any questions: We have the answers.
Our contribution to the validation of your devices:
Safety and functionality guaranteed
- Validation of IVD medical devices incl. software: Preparation of a plan, support for execution (clinical trials, usability), preparation of a report;
- Process validation;
- Transport and cleaning validation.
Our QM team is happy to contribute its share that all of your production processes comply with all QM requirements.
Contact usScientific validity, analytical performance and clinical performance
The IVDR requires you to demonstrate the following relationships and abilities of your product as part of your performance evaluation. The results are then jointly incorporated into the performance evaluation report (PER):
1. Scientific validity
Scientific validity means the association of an analyte with a clinical condition or a physiological state. Usually, the association has already been scientifically proven, but this must be documented.2. Analytical performance
The analytical performance of a device describes its ability to correctly detect or measure a particular analyte.
3. Clinical performance
The clinical performance describes the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.
Scientific validity means the association of an analyte with a clinical condition or a physiological state. Usually, the association has already been scientifically proven, but this must be documented.2. Analytical performance
The analytical performance of a device describes its ability to correctly detect or measure a particular analyte.
3. Clinical performance
The clinical performance describes the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.
Do your analytical performance tests count for verification and your clinical performance tests for validation? Or is validation in your case a clinical trial, possibly in combination with a usability test?We look forward to finding out more.
