What We do
Your eyewear specialists
We handle all the bureaucracy related to compliance with current regulations and provide assistance with everything your company needs to market its medical devices (MD) and personal protective equipment (PPE) within the European territory.
SERVICES
Responsible Person for Regulatory Compliance Service
The role of the PRC was introduced by EU Regulation 2017/745. It ensures compliance with regulatory obligations in terms of quality, safety, and performance of products by medical device manufacturers before being placed on the European Union market.
EC Representative for Non-EU Companies.
Appointing an Authorized Representative is a fundamental requirement for any non-EU company that wishes to market its medical devices in Europe. This service is designed to facilitate compliance with EU regulations, ensuring that products meet all the necessary legal and regulatory requirements for entry into the market.
The service also includes the function of PRC.
Technical files, model datasheets, and risk analysis.
We handle the writing of your complete Technical Files along with the Quality Management System. All turnkey.
Consultancy on regulations 745/2017 and 425/2016.
Establishment of the Post-Market Clinical Follow-up (PMCF) Protocol.
Review of compliance declarations, labels, and informational notes.
Annual audits to ensure your products' compliance and adherence to regulations.
Assistance with registration on the national and Eudamed database.
Product Specialist
We support the production of your collections, working closely with your in-house team. Leveraging our extensive experience and our network of proven partners, we enable your organization to concentrate on marketing, sales, and customer support, ensuring seamless integration and efficiency.
Audit
Should your company already hold the PRC, we will conduct a thorough review of your existing documentation. The purpose is to ensure compliance with regulations and to secure a positive outcome in the event of an inspection by the relevant authorities.
About Us
We help you see through it all
Navigating regulations can be a daunting task, requiring extensive knowledge and constant updates. We'll be by your side, simplifying this aspect so you can focus on sales operations with complete peace of mind!
Still have questions?
Use the form and we will contact you.
info@lagomconsulting.it
Via Sile 9, 31027 Spresiano TV
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