Quality Assurance
From ISO and ISTA standards to FDA regulations, our quality assurance services meet requirements and support a successful medical device supply chain management process.
Life Science Outsourcing’s quality assurance solutions were devised by experienced professionals who have a deep understanding of the supply chain management process.
Ensuring Compliance and Product Integrity
Quality assurance is essential to protecting patient safety, maintaining compliance, and ensuring product integrity. As part of our end-to-end solutions, we implement rigorous inspections, lot traceability, and regulatory compliance measures to meet the highest industry standards. With LSO, you can trust that every product is verified, documented, and ready for market.
What is quality assurance?
Fulfillment distribution requires strict quality assurance (QA) processes and procedures for consistent medical device production and ensures that products are controlled by the right quality standards. Examples would include verification of product specifications, packaging integrity, and proper labeling before product distribution.
Quality assurance can involve:
Inspection and testing
Routine checks during packaging and distribution
Documentation
Maintaining records for traceability and to identify any deviations from quality standards
Corrective actions
Implementing procedures for handling quality standard deviations
Who needs quality assurance?
Medical device manufacturers, contract manufacturers, and distributors all need quality assurance processes to maintain overall product quality, meet regulatory standards, and to facilitate handling and storage conditions that do not compromise product quality.
Proper quality assurance can support patient safety, safeguard brand reputation, and meet regulatory compliance requirements.
How does quality assurance work?
The LSO enterprise resource planning (ERP) system controls all order processing and inventory control. Unlike many fulfillment houses still utilizing paper systems with no verification, Life Science Outsourcing’s Fulfillment and Distribution services inspect shipments for sales order accuracy, product accuracy, lot tracking accuracy, and overall packaging.
To verify all inbound shipments, we ask our clients to provide a simple file for all inbound Purchase Orders. Once received, the goods will go through the Fulfillment & Distribution receiving inspection department before going into inventory
FDS complies to Internal and External customer requirements including a secured GMP warehousing facility, Lot traceability and FIFO.
What standards apply?
Certifications and certificates:
- ISO-13485
- FDA registered
- ISO-9001
- ISTA International Safe Transportation Association
- ASTM International
- 21 CFR compliant
Why LSO?
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica