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Regulatory Consulting: Support in submitting the process for certification by a Notified Body

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 08b4d7fb-bcf6-4019-a7fe-139ce2a220ed

Service Description

IPN team is able to bridge the gap between companies and the Notified Bodies. More specifically, the team supports the management of communication with the Notified Bodies during the certification submission process. This support includes guidance and support for the Notified Body selection according to the applicable product codes, assistance in requesting quotes, filling in the form, Gap analysis of the TD prior to submission and support in responses to Notified Bodies’ requests for additional information about submissions.

Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

Operational Details

Certification Support CE Marking (MDR, IVDR)

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