How might a Regulatory and Quality Assurance Consultant 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 person is to ensure compliance with stringent regulatory requirements imposed by health authorities such as the Food and Drug Administration (FDA), Health Canada, or Notified Bodies in Europe.

 

A report by Mordor Intelligence Research & Advisory estimates the Global Healthcare Regulatory Affairs Outsourcing Market to grow at a CAGR of 8.74% during the forecast period (2023-2028). This is due to several factors, including a shift in the MedTech industry, where SMEs have come to rely more on external expertise instead of building large and costly Regulatory departments.

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

 

Regulatory plan 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 clinical evidence to support the claims of safety and effectiveness made.

 

Pre-submission planning Once a regulatory strategy is finalized, a consultant 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 Medical Device Software, ISO 27001 for information security, device packaging validation, labelling requirements, human factor testing etc.

 

Regulatory submissions A consultant 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 consultant can help you establish a QMS (or eQMS), optimize it for redundancies and effectively maintain it to secure future audit successes and recertifications.

 

Post-Market Surveillance A consultant 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 A consultant 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 consultants 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.