Risk Management - ISO 14971

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Risk Management - ISO 14971

Risk Management

Need support getting your risk management file ISO 14971 compliant?

Medical device companies must have established a risk management process that complies with ISO 14971. ISO 14971 is formally recognized as the risk management standard by regulatory authorities in the US, Europe, Canada, Australia, and more. ISO 14971 improves your organization's ability to reduce uncertainty, and your ability to achieve the critical objective of ensuring device safety and effectiveness.

ISO 14971 helps your company with a systematic process to manage the risks associated with the use of a medical device and In vitro diagnostic. To maximize the effectiveness of your risk management system, ISO 14971 should be part of your quality management system (QMS) as required by ISO 13485.

Our experts understand what it takes to manage process interactions to produce the desired outcome: patient safety. Qserve's team of RA/QA consultants can help you understand and comply with the requirements of ISO 14971:23019 in global markets in an efficient, cost-effective way.

Our Risk Management Services

Planning - Define the scope of risk management activities and integration with your QMS.

Documentation - Identify gaps and opportunities to improvement.

Risk Analysis - Helping manufacturers focus on and address risk management activities to effectively analyze the risk associated with their devices.

Post Market Surveillance (PMS) - Making Risk Management complete and ensuring PMS feeds into Risk Managament.

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Qserve can help you with all your medical device and IVD risk management needs from trainings to the basic structure and requirements of ISO 14971: 2019 and EN ISO 14971: 2012 or the content deviations in Annex Z of EN ISO 14971: 2012, “how- to ”workshops on how to implement the risk management process and risk management framework within your organization to gap analyzes from your current risk management system to the requirements of ISO 14971: 2019 or EN ISO 14971: 2012 or help with implementing risk controls or mitigating risk .

Qserve can also help with the implementation of some of the new and more complex topics brought in by MDR and IVDR, such as the connection between manufacturing controls and risk management discussed in Annexes VII and IX of the MDR, for example, as well as language in the PMS plan, CEP and SSCP which may push us in a more quantitative risk management direction than was the case historically under MDD - eg

Annex III - indicators and threshold values for continuous benefit-risk - in 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 - in the CEP ,
Risk quantification in SSCP - MDCG 2019-9

Qserve can assist with the interpretation and practical implementation of these aspects too.

With many former Notified Body employee on staff, we are also in a great position to help you make the connections between your Risk Management Report (RMR) & risk controls and Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP) , IFU & labeling and Design Verification and Validation (DV&V or “performance testing”) to check for consistency in terms of risk controls and warning / precautions / contraindications & information for safety, disclosure of residual risk, sample sizes and reliability estimates from DV&V testing and occurrence of hazardous situation occurring, clinical data and occurrence of harm and so forth.

Moreover, we can help with the newer challenges of cybersecurity and the related risks and how to manage them (eg following the concepts in MDCG 2019-16) and risk management for devices with no medical purpose (so-called “Annex XVI” devices) which require the use of Common Specifications and meeting GSPR 9 of the MDR.

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