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 device(s) 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, analyzes and controls the hazards associated with the use of the device to ensure patient and user safety.

With Med'in QARA, I help you set up a process that is integrated into the design and linked to activities such asFitness for Use orClinical 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.

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).

The chemical and biological assessment, or Biocompatibility, in accordance withISO 10993, 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 - essential documents in Technical Documentation.

Devices must be clinically validated to demonstrate their safety and efficacy, in compliance with Regulation (EU) 2017/745 and ISO 14155.

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 lifetime.

This step ensures that the device retains its integrity and performance 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 arguments to guarantee transparency and adherence to good design practices, and compliance with current standards.

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