Medical Device Regulatory Consulting

Medical device companies today face an evolving regulatory landscape where entry into different markets comes with more hurdles than ever before and maintaining compliance requires a continuous, almost herculean effort. In the regulatory process mistakes, however big or small, can result in unnecessary expenses or a delay in market entry, risking the crucial first mover’s advantage. With such a quickly changing regulatory market, extensive experience in the implementation of regulatory strategies is key to obtaining regulatory approvals and maintaining compliance with post-market requirements worldwide.

Role of a Regulatory Consultant

Regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines and can recommend the right course of action for an organisation. They are equipped to guide manufacturers on the complexities of the regulatory requirements, globally, and advise them on the most efficient regulatory path for approval and device registration. Regulatory strategic planning from design to market ranges from defining the product development plan, preparing clients for Agency meetings, and providing guidance on the most expedited path to marketing the device under evaluation.

Assessment and determination of the classification of Medical device and IVDs

Maneuver complex medical device and IVD regulatory requirements for a better Global Market strategy Consultants are very familiar with opaque regulatory processes and have a deep-rooted, thorough understanding of complex national regulations and where they overlap such as: 1) European Clinical Evaluation Report (CER) preparation 2) EU MDR 2017/745 gap assessments and transition consulting 3) Risk management planning and ISO 14971 implementation 4) FDA UDI compliance consulting Their expertise in maneuvering regulations allows them to leverage existing data eg clinical studies for quicker, less-expensive submissions. Consultants are equipped to develop customized regulatory strategies that leverage existing registrations. Regardless of the number of medical devices, EU MDR consultants can help companies expand market reach to major and emerging markets worldwide.

Achieve QMS compliance in medical device markets worldwide

In most markets in order to obtain device approvals and registrations, regulatory bodies mandate device companies to maintain a quality management system. Depending on the market, certification to international standards like ISO 13485 or compliance with a local quality management regulation is required. If companies do not comply with these quality system requirements, it will not only stand in the way of approvals and registration, but may also jeopardize standing with regulators post-market and disrupt product sales. Regulatory consultants can leverage their decades of experience to develop, implement, and maintain integrated quality management systems that comply with QMS regulations in all major medical device markets. Establishment and maintenance of a quality management system that meets QMS requirements is key to product sustenance. Through every step of the process, consultants can support companies with gap analyses, due diligence, and internal, supplier, and pre assessment audits, including writing quality management system procedures, conducting and monitoring the implementation, and training employees. Consultants can also assist in maintenance and on-going compliance of QMS following implementation and certification (where applicable). A lifecycle approach focuses on risk management which must be incorporated in processes throughout the business. The optimal approach here is to integrate risk management into quality management systems.

Breaking Down the Medical Device Regulatory Consulting Process

Regulatory consultants carefully scrutinize client data to ensure its adequacy and accuracy. They guide and advise clients beforehand so that the submitted data fully meets the requirements for product registration, and eliminates any delay risk. An independent review of the available data identifies any potential deficiencies prior to the submission and ensures that they are corrected during the dossier development process itself. Through an efficient project management process, a project milestone plan is created and communicated to the client. Once the client is satisfied with the rationale and timeline of the draft plan, the project is initiated for subsequent delivery on time. Post the acceptance of the submission by the relevant regulatory authority, product registration takes place in a timely manner. In case a query is raised by the concerned authority, consultants help put together a robust, scientific response which expedites the process of obtaining the product registration. Consultants help ensure that all vital information required by regulatory authorities in terms of quality of the product, safety, efficacy, analytical data, validation protocol, etc. is addressed effectively. Through the development of a detailed regulatory submission strategy consultants help assist in the preparation of the dossier documents pertaining to product registration in accordance with the guidelines and regulations of concerned countries.