Structured dialogue is a focused exchange between a medical device manufacturer and our appropriate experts. It provides an opportunity to clarify regulatory requirements, conformity assessment procedures and information expectations before or during the conformity assessment process.
Navigating medical device conformity assessment can raise complex regulatory, technical and procedural questions. Manufacturers often need clarity on specific requirements, documentation expectations and next steps as they prepare for or progress through MDR and IVDR conformity assessment.
Structured dialogue gives medical device manufacturers the opportunity to engage directly with our experts to gain greater clarity on regulatory requirements and the conformity assessment process. This is not a consulting service: we clarify applicable requirements and explain what the process involves, while responsibility for determining and implementing your compliance approach remains with your organization.
Gain greater clarity throughout the conformity assessment process
- Clarify requirements
Clarify applicable regulatory and conformity assessment requirements for your device.
- Understand documentation expectations
Recognize what information and documentation the process expects.
- See the assessment process
Gain greater visibility of the conformity assessment process and next steps.
- Address specific questions
Raise regulatory, technical or procedural questions directly with our experts.
- Improve efficiency
Improve the efficiency and predictability of your interactions with us.
How does Structured Dialogue work?
Structured Dialogue is built around your specific questions.
Before the discussion, you provide SGS with the topics or questions you would like to address. We identify the appropriate experts and arrange a focused discussion based on the scope of your request.
During the dialogue, our experts can provide clarification on applicable requirements, conformity assessment procedures and information expectations.
This helps you better understand the requirements while ensuring that responsibility for determining and implementing your compliance approach remains with your organization.
Why SGS?
As the world's leading testing, inspection and certification company, we combine regulatory expertise with extensive industry experience as a trusted provider of medical device conformity assessment and certification services. Our global network of medical device specialists helps you better understand complex conformity assessment requirements while maintaining the independence, objectivity and impartiality required of a Notified Body.
Disclaimer
Structured dialogue is not a consulting service. We do not provide advice or solutions on how manufacturers, authorized representatives or suppliers should meet regulatory requirements, including recommendations relating to the design, construction, marketing or maintenance of devices or processes. Instead, structured dialogue focuses on clarifying which regulatory requirements apply and helping you better understand the conformity assessment process. Where appropriate, we may highlight relevant regulatory requirements and refer to applicable regulatory or technical guidance.
FAQs
No. Structured dialogue is not a consulting service. We can clarify regulatory requirements and explain what needs to be addressed as part of the conformity assessment process, but we cannot provide solutions or instructions on how your organization should achieve compliance. Responsibility for determining and implementing your compliance approach remains with your organization.
Structured dialogue is built around your specific questions. Before the discussion, you provide us with the topics you would like to address, and we identify the appropriate experts and arrange a focused discussion based on the scope of your request. During the dialogue, our experts provide clarification on applicable requirements, conformity assessment procedures and information expectations.
Topics may include conformity assessment and certification processes, application and pre-application procedures, documentation and information requirements, applicable conformity assessment routes, regulatory and administrative requirements, technical or procedural questions and expected process steps and timelines. The appropriate scope depends on your device, regulatory pathway and stage of conformity assessment.
Structured dialogue can clarify applicable requirements and what information is expected. However, we cannot develop your documentation, recommend specific solutions or tell you how to modify your documentation to achieve compliance.
No. Structured dialogue does not guarantee a particular conformity assessment or certification outcome and does not influence future certification decisions.
Structured dialogue may take place before or during the conformity assessment process, depending on the questions you would like to address and the applicable regulatory requirements.
Participants will depend on the topics being discussed. We will identify appropriate medical device experts based on the scope of your questions.