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Regulatory Affairs

Gap analysis of Technical Documentation for Medical Devices and IVDs

Classification of medical devices and IVDs

Preparation of the technical documentation

Labelling compliance analysis

Risk analysis activities

Supporting PMS activities

Biological Evaluation Plan e Report

Survey evidence builder

SSCP for Medical Devices: Safety and Clinical Performance According to MDR

Clinical evaluations (MD), PMCF and SSCP

Assistance for the import of for Medical Devices and IVDs

Support for access to non-EU markets

Medical Device and IVD advertising authorisation

Assistance in interacting with the Notified Body

Person Responsible for Regulatory Compliance

Eudamed and Italian Databases Registration

Regulatory Due Diligence

Usability assessments

Regulatory helpdesk

Regulatory training

Quality management systems

Preparation of QMS documentation

Gap Analysis of the QMS from Directive to Regulation

Gap Analysis of the QMS against ISO13485 requirements

Consulting for distributors and importers of medical devices and IVDs

Process Validation

Internal audit

MDSAP audit

Supplier audits

Expert Preparation and Coaching for Certification Audits

Medical writing and scientific communication

Medical Writing

Clinical writing

Data analysis

Texts and content

Visual communication

The handbook for the pharmaceutical sales representative

Advisory boards

Presenting data at scientific events

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Regulatory affairs

SSCP under MDR: the key document to communicate safety and performance.

27 October 2025
Valentina Tomaello
SSCP: the document that makes a medical device’s safety visible. It’s not just a technical file—it’s a tool for public…
Regulatory affairs

Clinical data collection for medical devices: the role of PMCF surveys

16 September 2025
Federica D'Incà
Although Regulation (EU) 2017/745 on medical devices (MDR) does not explicitly mention surveys, they are recognized in applicable standards and…
Regulatory affairs

Survey PMCF: how to collect post-market clinical evidence effectively and in compliance

16 September 2025
Valentina Tomaello
PMCF surveys are effective tools for collecting post-market clinical evidence quickly, sustainably, and in compliance with the MDR, when well…
Regulatory affairs

IEC 62366-1: A Practical Guide to Usability Evaluation of Medical Devices

11 September 2025
Margherita Fort
IEC 62366-1 provides a structured approach to evaluating the usability of medical devices.Reducing use-related errors means enhancing both safety and…

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