Medtech Engineering
Risk Management
Every MedTech project at Perdigó involves a systematic
process to identify, evaluate, and mitigate potential risks associated with the device throughout its lifecycle.
The engineering team uses specialist software tools and
methodologies such as Failure Mode and Effects Analysis (FMEA) or Use-Related Risk Analysis (URRAH).
The process is documented in a project-specific Risk Management Plan (RMP) and Report, ensuring compliance with regulatory standards such as ISO 14971.
Technical Documentation
Perdigó prepares comprehensive and well-structured records that demonstrate its designs have been developed in accordance with the approved plans and regulatory requirements.
These documents form the device Design History File (DHF) and Device Master Record (DMR) for successful Premarket Approval (PMA) by the FDA. Equivalently, the Technical Documentation (formerly Technical File) supports CE marking in the European Union.
Quality Management
Perdigó’s Quality Management System (QMS), which is accredited to ISO 13485, covers the full scope of research, design and development of medical devices, In Vitro Diagnostics, and biotechnology equipment.
This ensures effective, transparent, and efficient compliance of each project with the high standards expected by companies and regulatory authorities globally.
Project Management
The Project Plan is a key aspect of the Technical Documentation of a medical device. From large pharmaceutical companies to ambitious start-ups in healthcare, Perdigó provides tailored, proactive and experienced project management, ensuring clear and timely communication.
Focusing solely on MedTech, Perdigó has extensive experience collaborating with other healthcare stakeholders, including hospitals, Contract Manufacturing Organisations (CMO), regulatory consultants, Contract Research Organisations (CRO) and other suppliers.
