Med'In QARA - Design and Development

The " worst-case " designates the most stringent product(s) in a range, chosen to represent the range during design verification and validation testing. The tests carried out on these devices ensure the performance, safety and conformity of the entire range.

Sampling, on the other hand, involves selecting a representative set of products for testing, on the basis of statistical plans based on acceptance criteria that rely on levels of confidence and reliability, to ensure that the results obtained reflect the overall performance of the device.

Med'In QARA can help you set up sampling in compliance with standard statistical techniques.

Risk management, as required by ISO 14971, enables identified hazards to be analyzed and controlled throughout the device's lifecycle, from design to disposal.

With Med'in QARA, I can help you set up a risk management process that is integrated into the design and linked to various activities such as usability engineering or clinical evaluation.

IEC 62366 requires devices to be designed with the end-user in mind. The aim is to minimize user errors and ensure product safety and efficiency.

This objective can only be achieved by setting up an usability engineering file, incorporating the results of formative and summative studies.

Regulations stipulate that verification tests should preferably be carried out by accredited laboratories (ISO 17025) to guarantee the validity of results and compliance of the device with specifications, whether for performance, safety or biocompatibility tests (ISO 10993).

When design verification tests are internalized, they must be subject to prior method validation.

The chemical and biological assessment, or biocompatibility, compliant with the ISO 10993 series of standards, analyzes the safety of the device in contact with the human body.

Med'In QARA helps you set up your Biological Evaluation Plan and draw up your Biological Evaluation Report, based on the results provided by experts in the field (analysis and testing laboratories, and toxicologists), essential documents in Technical Documentation.

Devices must be clinically validated to demonstrate their safety and efficacy, in compliance with regulatory requirements and standards (ISO 14155).

Animal studies can also be carried out to confirm and/or demonstrate clinical performance, with a view to or in place of clinical investigation.

Our team is here to help you.

Shelf-life and ageing tests, whose durations are established using ASTM F1980, confirm that the device remains compliant and performs well over its expected shelf-life and lifetime.

This step ensures that the device retains its integrity and performances during transport to the end user. It is based in particular on ASTM D4169 or ISTA procedures.

The justification of certain technical decisions requires the drafting of rationals to guarantee transparency and adherence to good design practices, and compliance with in force standards.

Med'In QARA can assist you in the drafting or external review of these rationals.