Simplifies software validation with structured, ISO-aligned documentation.
AUDIT-READY WORKFLOWS
Ensures traceability and documentation for internal and external audits
SUPPORT MDR AND UDI REQUIREMENTS
Enables full traceability across lenses, materials, and processes
RELIABLE AND CONTROLLED PROCESSES
Maintains consistent workflows aligned with medical device standards
PREPARED FOR VENDOR QUALIFICATION
Supports vendor risk and cybersecurity assessment requirements
ISO CERTIFICATION
Advance Medical has implemented and maintains a Quality Management System for the scope of “Design of prescribed Contact Lenses and Provision of associated services of training, maintenance and SW Validation" fulfilling the requirements of the ISO 13485:2021 standard.
The proven quality of our Software is one of the essential requirements for building a relationship of trust with all stakeholders. It reflects our commitment to continual improvement and gives FocalPoints customers confidence in our ability to bring effective products and services to market.
FocalPoints supports laboratories operating under MDR and UDI requirements by ensuring traceability of lenses, materials, and manufacturing processes. Structured data management and process control simplify compliance and reduce regulatory risk.
Advance Medical provides software validation support aligned with ISO 13485 requirements. Our approach helps laboratories document and validate their systems efficiently, reducing the burden of compliance while ensuring consistent and auditable processes.
As digital workflows become central to laboratory operations, cybersecurity is an essential part of compliance. Advance Medical actively promotes awareness across the industry through initiatives such as EFCLIN lectures, while continuously strengthening internal practices to address evolving risks in connected manufacturing environments.
How does your ISO 13485 certification benefit my lab?
It ensures that our processes, software, and services follow recognized medical device standards, helping your lab operate with greater consistency, traceability, and confidence during audits. Working with an ISO 13485–certified supplier also substantially simplifies your own audit process, reducing the level of scrutiny and documentation required.
Does FocalPoints support MDR and UDI compliance?
FocalPoints links key manufacturing activities to each lens job history, providing structured traceability across lenses, materials, and processes. While certain operations may occur outside the system, the platform supports MDR and UDI requirements through controlled data management and integrated packaging modules for compliant labeling.
Can Advance Medical support vendor qualification processes?
Yes, our organization is structured to support vendor qualification requirements, including vendor risk and cybersecurity assessments, as typically requested by large medical device manufacturers. We also maintain a Business Continuity Plan, with processes designed to support service reliability and stable operations. This helps customers address internal qualification needs and supports confidence in ongoing collaboration.
How do you approach cybersecurity in laboratory environments?
We combine secure system design with ongoing awareness initiatives, including industry contributions such as EFCLIN lectures, while continuously improving internal practices to address evolving cybersecurity risks.
EXPLORE THE RIGHT SETUP FOR YOUR LAB
Every lab works differently. Explore how FocalPoints adapts to your processes and manufacturing goals with the right combination of features and modules.
