How might a Regulatory and Quality Assurance Advisor help?

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Medical device regulatory consulting is a specialized service that assists manufacturers, developers, and stakeholders in navigating the complex landscape of regulations governing the design, production, and marketing of medical devices. The purpose of medical device regulatory advisor is to guide innovators through complex regulatory requirements imposed by health authorities such as the Food and Drug Administration (FDA), Health Canada, or Notified Bodies in Europe.

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Below is a breakdown of the various aspects of medical device development that a Medical Device Regulatory and Quality Assurance advisor can assist you with:

 

Regulatory Strategy Typically contains a risk classification, the specific requirements that a manufacturer needs to meet to market their medical device, including standards, quality management system requirements and the clinical evidence to support the claims of safety and effectiveness made.

 

Pre-submission Planning Once a regulatory strategy is finalized, an advisor can help with the pre-submission planning and management including assisting in preparing for pre-submission meetings with regulatory agencies and ensure alignment with the regulator’s current thinking.

 

Technical Documentation Examples of testing that a consultant can guide the R&D or NPI team with include Design Verification and Validation, harmonized standards, i.e. ISO 14971 for risk management, IEC 60601 for Medical Electrical Equipment, ISO 10993 for Biocompatibility, IEC 62304 for Medical Device Software or SaMD (Software as Medical Device), ISO 27001 for information security, device packaging validation, labelling requirements, human factors testing etc.

 

Regulatory submissions A regulatory advisor can also help with preparing and compiling regulatory submissions, including Investigational Device Exemptions (IDE), 510(k) submissions, Technical Documentation for CE Marking and interface with regulatory agencies during the submission review process to address questions raised by the regulator and provide clarifications.

 

Quality Management Systems (QMS) Required by most regulators for devices of Class II and above, a Quality Assurance advisor can help you establish a QMS (or eQMS) in accordance with the ISO 13485 and/or MDSAP, optimize it for redundancies and effectively maintain it to secure future audit successes and recertifications.

 

Post-Market Surveillance An advisor can help establish post-market surveillance systems to monitor the device's performance and safety once commercialized and tackle any post-market compliance issues, reporting obligations, remediation efforts etc.

 

Gap analyses An advisor can also help conduct gap assessments in preparation of an upcoming inspection and provide strategies for improvement. These can be a result of internal audits of the QMS and/or technical documentation.

 

Education Medical device regulatory advisors play a pivotal role in educating companies through the intricate regulatory landscape, ensuring that their products meet the necessary standards for safety, efficacy, and quality while building in-house expertise to enable teams to effectively maintain their operations without ongoing reliance on a consultant.