Conformity Assessment: The activity of the product/process/organisation that complies with the standard or requirement clauses. Notified Bodies perform conformity assessments and grant certification as a proof/result of the conformity assessment.
Benefit-Risk Ratio: A medical device has to have more benefits than its risks; therefore, during and after the product development, the manufacturer has to make an active risk/benefit assessment and ensure that the device’s benefit exceeds the risks.
Design Controls: A structured way of product design within the medical device industry. It practically is defining the user/product requirements, checking if all requirements are met by testing(verification), reviewing if the right product is designed(validation) once all the requirements are met releasing the product into the market. All medical device products have to be developed with a design controls strategy; conformity assessment carried out by NBs, and other product standards enforce this method to the manufacturers.
Medical device regulation aims to ensure that patients have access to high-quality, secure, and efficient medical devices while preventing access to unsafe prepared products. Medical Device Regulation guarantees public health benefits and the protection of patients, health care staff, and the general public in the European Union. The latest European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union. The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices in Europe.
Product safety is provided for medical device packaging to keep the integrity of the package throughout its entire existence, including sterilisation, delivery, storage, handling, and use.
Statistical Sampling: It is the approach of how many products you want to test in which scenario; this approach has to have a scientific, statistical validity. Statistical Sampling is a part of verification/validation and also clinical evaluation.
Transport validation aims to ensure that the product is not affected by external factors, while also collecting useful information about the expected performance of the packaging during transportation.
If you have a product line that consists of medical devices in a variety of sizes or models or various quantities, determining the worst-case product scheme is a little bit tricky, especially when the worst-case scenario does not refer exclusively to the system or package. Considering the worst-case situations like mass, size, geometry, configurations, and different processes is essential if you want your sample for testing to represent all your product lines.
CE-Certification: This is the conformity assessment per relevant regulation on the product. It literally stands for European Conformity's french version Conformite Europeenne. All products: laptops, phones, ovens have to have a CE mark to pass the appropriate safety level for the EU public. For medical devices, it also stands for market clearance; without CE Certification other than Class I products, a manufacturer cannot place their products on the EU market.
The GSPR, known as General Safety and Performance Requirements, is the director of any medical device CE marking. The GSPR has 23 requirements under MDR and 20 requirements under IVDR. The manufacturers who want to get their device CE marked must comply with these requirements and have sufficient evidence and conformity evidence to prove that they have complied with the GSPR.
Any instrument, equipment, implant, unit, appliance, in vitro reagent, software, or other similar and related device used for specific medical purposes is referred to as a medical device.
A quality management system (QMS) is defined as a formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
The packaging around medical devices that allows those devices to be sterilised provides a microbial barrier and maintains sterility effectively up to the point of use is known as a sterile barrier system. A sterile barrier system is an essential part of a sterile medical device.
It is undeniable that your medical device design is superior in certain engineering aspects. Have you considered the human factor? Usability is a statistical study that assesses how well a particular user in a specific situation can use a product/design to accomplish a given purpose effectively, efficiently, and satisfactorily. EN / IEC 62366-1 standard describes the application of human nature, skill, shortcomings, and other characteristics to the design of medical devices (including software), structures, and tasks to ensure sufficient usability.
Conformity Assessment: The activity of the product/process/organisation that complies with the standard or requirement clauses. Notified Bodies perform conformity assessments and grant certification as a proof/result of the conformity assessment.
In vitro diagnostic medical devices (IVD) are tests used on biological samples (such as tissues, blood, or urine) to determine the status of a person's health. Unlike medical devices or pharmaceuticals, IVDs never come into contact with a person. IVDs do not treat patients but provide information about the functioning of the body. IVDs do not cause direct harm but may pose risks if their use leads to an incorrect diagnosis.
Notified Body: The certification body that conducts conformity assessment at the manufacturers on behalf of the competent authority, usually the health ministry. It depends on the classification of the product whether or not the involvement of NB is needed. Low-risk products-Class I do not require notified body involvement. All the other classes of products require notified body involvement and notified bodies to perform the CE Marking and Quality management System assessments.
There are common challenges with application, design, and process in every medical device, from software to the implant. Risk management is the forecasting and assessment of those challenges, as well as the detection of procedures to prevent or mitigate their effects. EN ISO 14971:2019 standard illustrates how to incorporate an effective risk management system for medical devices.
Sterilization refers to any process that removes, kills, or deactivates all forms of life and other biological agents like prions present on a specific surface, object, or fluid. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration. After sterilization, an object is referred to as being sterile or aseptic.
Validation simply checks if the right device or procedure is designed. In a typical medical device design, requirements are set (however can be changed later) at the beginning of the device development. Validation is checking the final product or process fulfills the initial requirements that the manufacturer determined. Since it is not practical to remember the requirements at every stage of product development, this final stage validation check gives a level of confidence if the right product or process is designed.
