bytec Legal Manufacturer provides regulatory and quality management services for medical device manufacturers. They act as a legal manufacturer for clients, ensuring compliance with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements. This allows companies to bring their medical devices to market in Europe without establishing their own extensive regulatory infrastructure.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device companies face increasing complexity and costs in navigating EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements. Many companies struggle to allocate sufficient resources and expertise to maintain compliance throughout the entire device lifecycle, potentially delaying market access or forcing product line discontinuation.
Solution
bytec Legal Manufacturer provides comprehensive regulatory and quality management services, acting as a legal manufacturer to ensure medical devices comply with EU MDR and IVDR standards. The company offers Legal as a Service, assuming responsibility for regulatory compliance so that clients can focus on product development and innovation. bytec Legal Manufacturer guides clients through the regulatory landscape, offering support from initial market launch to ongoing maintenance, including quality management system implementation, audit preparation, and technical file management. They also act as an EU Authorized Representative for manufacturers based outside of Europe, ensuring their products can be legally sold within the European market.
Target Audience
The primary target audience includes medical device manufacturers seeking to outsource their regulatory and quality management responsibilities to ensure compliance with EU MDR and IVDR, as well as companies outside of the EU looking to enter the European market.
Features
- Legal Manufacturer services, assuming full regulatory responsibility for medical devices under EU MDR/IVDR
- EU Authorized Representative services for non-EU manufacturers
- Quality Management System (QMS) development and implementation according to ISO 13485
- Audit preparation and support, including supplier audits and internal audits
- Regulatory Affairs consulting, covering classification, essential requirements, and clinical data management
- Technical documentation review and maintenance
- Post-market surveillance (PMS) and vigilance reporting
- EUDAMED database registration and maintenance