CONSULTING – EXPERTISE & OPERATIONAL SUPPORT

ORIOS LifeSciences provides specialized consulting and operational support to medical device companies, healthcare organizations and other regulated industries.

Our multidisciplinary team supports customers in addressing critical technical, regulatory, quality and operational challenges throughout the product lifecycle.

Our consulting activities cover four major areas: R&D and Design, Operational Excellence, Regulatory Compliance and Quality Assurance.

In R&D and Design, we support customers with product design reviews, technical feasibility assessments, industrialization strategies and optimization of existing devices and processes. Regulatory and manufacturing constraints are considered from the early stages of development to secure the transition toward industrial production.

Our Operational Excellence experts help companies audit, optimize and secure their manufacturing processes. This may include investigation of defects and non-conformities, process mapping, qualification and validation of manufacturing lines, and deployment of Lean, Six Sigma and other continuous-improvement methodologies.

Our objective is to improve yield, reduce costs, increase process robustness and ensure reproducibility while maintaining compliance with applicable requirements such as ISO 13485 and GMP.

Our Regulatory Affairs services include:

• ISO 13485, MDSAP and MDR readiness assessments
• Mock audits and gap assessments
• Critical supplier audits
• MDR and IVDR gap analysis and remediation
• Risk management according to ISO 14971
• Biological risk support according to ISO 10993
• Technical documentation preparation and remediation
• Support for CE marking, FDA submissions and 510(k) activities

Our Operational Quality Assurance support includes the management and investigation of:

• Deviations
• CAPAs
• Complaints
• Change controls
• Non-conformities
• Remediation plans

ORIOS can also design, optimize or restructure Quality Management Systems to make them compliant, efficient and aligned with the customer's operational and business objectives.

We also provide outsourced PRRC support, covering product compliance verification, technical documentation, declarations of conformity, interactions with authorities and notified bodies, and post-market surveillance activities.

Our approach is pragmatic and collaborative. We work directly with customer teams, transfer knowledge and focus on solutions that can be implemented effectively in real industrial environments.

Whether you are a start-up, SME or global medical device manufacturer, ORIOS can provide targeted expertise or broader operational support according to your project's needs.

We are looking to connect with companies requiring senior expertise in R&D, industrialization, quality, regulatory affairs, process validation, manufacturing optimization or remediation.