Skip to content

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

PMCF

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

Find out more from our magazine

Scientific Communication

The role of the medical writer in the veterinary sector

Ester Musu
Who is the veterinary writer, what skills do they have, and in which areas do they operate? What impact does…
Regulatory affairs

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

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

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

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

Desideri avere maggiori informazioni sui nostri servizi?

CONTATTACI

Would you like more information about our services?

CONTACT US
ISCRIVITI ALLA NEWSLETTER

Ti aspettano approfondimenti esclusivi su temi caldi e attuali, aggiornamenti normativi, novità derivanti dalla nostra formazione e tanto altro. Non perdere l'opportunità di ricevere contenuti di valore direttamente nella tua casella di posta.

ISCRIVITI ALLA NEWSLETTER

SERVICES

Would you like more information about our services.

CONTACT US

ABOUT US

Corporate

Learn about the values that underpin our company, the ecosystem within which the people who work with us operate, the approach we take to customer relations, and the charity initiatives we have selected and supported over the years.

Work with us

Work with us

Find out about any vacancies, send your spontaneous application and find out about the job profiles of those who already work with us.

Programma segnalatori

Referral program

If you work in the life science sector, there is a new opportunity waiting for you. By participating in the Clariscience Referral Programme you can economically capitalise on your expertise and your network of contacts.

Would you like more information about our services?

CONTACT US