MDR Compliance Check
Q1. Do you have a certified medical device? *
Q2. Do you have a compliant UDI system already in place? *
Q3. Do you have a compliant labeling system already in place? *
Q4. Do you have experience with clinical investigations and writing clinical evaluations? *
Q5. Do you intend to sell a medical device in EU? *
Q6. How many SKUs (stock keeping units) are you planning to to sell in EU? *
Q7. Who are your partners to ensure regulatory compliance? *
Q8. Notified bodies are now in process of designation. Are you in discussion with your NB if the scope of the NB under MDR covers your device range? *
Q9. The transition normally starts with a GAP analysis. Did you already do such GAP analysis on the QMS aspects, technical documentation and clinical data documentation? *
Q10. Do you have enough resources available to cover the EU MDR workload? *
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Inspiralia and its Affiliates have at all times complied in all material respects with all applicable federal, state and local laws, statutes, regulations and/or legal requirements relating to privacy, data protection and the collection and use personal information and user information gathered or accessed in the course of the operations of Inspiralia or any of its Affiliates. Inspiralia and its Affiliates have at all times complied in all material respects with all rules, policies and procedures established by Inspiralia or any of its Affiliates from time to time with respect to privacy, data protection or collection and use of personal information and user information gathered or accessed in the course of the operations of Inspiralia or any of its Affiliates, current versions of which are set forth in Annex III of Inspiralia’s Services Agreements with its clients. No claims have been asserted in writing or, to the knowledge of Inspiralia, threatened against Inspiralia or any of its Affiliates by any person or entity alleging a violation of such person’s or entity’s privacy, personal or confidentiality rights under any such rules, policies or procedures. For purposes of this section, the term “Affiliate” shall mean any other person or entity that owns or controls, is owned or controlled by, or is under common ownership or control with Inspiralia. Further information in the following link: https://www.inspiralia.com/wp-content/uploads/2018/06/Privacy-Policy_Inspiralia_EN.pdf

After you submit the compliance check, we will contact you within 5 working days. You can also directly email us to info@inspiralia.com.

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