Qserve can support you in every aspect of risk management for medical devices and in vitro diagnostics, including trainings on ISO 14971:2019 and EN ISO 14971:2012, workshops on implementing the risk management process and framework, assessments of the current risk management system compared to ISO 14971:2019 or EN ISO 14971:2012 requirements, and assistance in implementing risk controls or risk mitigation measures.
Qserve can also aid in the implementation of new and complex subjects introduced by the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), such as the relationship between manufacturing controls and risk management as discussed in Annexes VII and IX of the MDR, and the language in the Post Market Surveillance plan, Clinical Evaluation Plan, and Summary of Safety and Clinical Performance which may drive a more quantitative approach to risk management compared to the previous Medical Device Directive (MDD).
- Annex III - indicators and threshold values for continuous benefit-risk in the PMS plan
- Annex XIV - a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with a clear reference to the determination of residual risks and side-effects; and an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device within the CEP plan
- Risk quantification in SSCP - MDCG 2019-9
Qserve can assist with the interpretation and practical implementation of these aspects too.
With several former Notified Body employees on our team, we are well equipped to assist you in linking your Risk Management Report (RMR) and risk controls to your Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP), Instructions for Use (IFU) and labeling, and Design Verification and Validation (DV&V or "performance testing"). This includes ensuring consistency in risk controls, safety information, disclosure of residual risk, sample sizes, reliability estimates from DV&V testing, hazardous situations, clinical data, occurrences of harm, and other related aspects.
Additionally, we can assist with the newer challenges of cybersecurity and related risks and provide guidance on managing them (following the principles outlined in MDCG 2019-16) and managing risk for devices without a medical purpose (known as "Annex XVI" devices) which require the use of common specifications and adherence to GSPR 9 of the MDR.