CH REP, UK REP, US AGENT to the FDA

Representation services for Switzerland, the United Kingdom and the USA; official representative role, communication with authorities and ongoing regulatory support.

EUDAMED and swissdamed

Registration support for EUDAMED and swissdamed; support throughout the registration of medical devices in the EU and in Switzerland.

Person Responsible for Regulatory Compliance (PRRC)

PRRC services for medical devices and regulatory compliance; ongoing support for compliance programmes, risk management and regulatory obligations.

Technical Documentation Files Drafting

Drafting technical documentation dossiers for regulatory submissions; compilation of design, manufacturing and quality documentation.

Clinical Evaluation

Clinical evaluations for medical devices; analysis of clinical data, literature, clinical experience, and preparation and updating of reports.

Postmarket Surveillance

Postmarket surveillance for medical devices and combination products; planning of PMCF studies, literature analyses, market monitoring and updating of clinical evaluations.

Performance Evaluation

Performance evaluation for IVD devices; scientific literature search, expert assessments, studies and ongoing updating of documentation.

Classification and Regulatory Strategy

Classification and regulatory strategy for medical devices, IVD, software and laboratory equipment; regulatory classification, path selection and market strategy.

CE marking, FDA and global product registrations

Support for CE marking, FDA approvals and global product registrations; technical dossiers, submissions and interaction with authorities.

Evaluation and Monitoring of Applicable Regulations, Standards, and Guidances

Ongoing monitoring of relevant regulations, standards and guidance documents; assessment of changes and their impact on products and operations.

Interaction with Competent Authorities (e.g., FDA, EMA)

Communication with the FDA, EMA and other authorities; preparation of meetings, answering follow-up questions and support with submissions.

MDR Art 117

Preparation and review of technical documentation according to MDR Article 117 for combination products; submission to the Notified Body for an opinion.

confinis ch-rep ag

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confinis ch-rep ag

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