Medical & Life Sciences

We provide product development and engineering support to our clients at every stage of the product lifecycle, from conceptual design to prototyping and testing.

We work closely with our clients to offer

• Design and development support to ensure that all medical devices and systems adhere to the highest safety and efficacy standards.
• Redesign support wherever necessary to maximize product value within a compliant framewor
• Robust manufacturing evaluation approach using a series of controlled reviews with our clients, applying process capability and engineering design of experiments (DOE) tools
• Engineering change control analysis to provide documented and correctly controlled processes for all product life stages

QFocus offers several capabilities in manufacturing engineering operations that are indispensable to the production of medical devices:

• New Product Introduction (NPI) services support the development and commercial manufacturing of products, offering seamless transition across both phases.
• Product and process line transfer capabilities ensure ease of technology migration cross production facilities
• Effective scientific injection molding expertise for precision plastic component manufacturing requirements
• Sophisticated research methodology and software-driven DOE optimization coupled with exhaustive training curriculum to upskill teams with advanced molding process knowledge

Additionally, our manufacturing operations support includes Value Stream Mapping (VSM), takt time optimization, lean manufacturing implementation along with providing technical assistance, automation, process improvements and timely implementation of upgrades to ensure high operational efficiency.

Regulation is imperative for the medical and life sciences industry and brings challenging compliance requirements around quality and validation. QFocus’ suite of quality and validation services include

• Equipment & Process Validation, including Installation Qualification (IQ), Performance Qualification (PQ) and Operational Qualification (OQ) protocols to ensure that all the systems operate optimally and appropriately
• Software & Test Method Validation: Software systems and analytics validation to meet FDA and global regulations
• Quality Documentation: QFocus’ comprehensive quality documentation packages are curated by subject matter experts (SMEs) to include quality testing and control frameworks, plans and execution metrics capable of satisfactorily passing external regulatory auditor scrutiny
• Risk Management: We support PFMEA execution, risk-driven statistical reviews and control plan documentation to improve process outcomes and diminish exposure to production risks

Supply chain continuity is supreme for medical devices manufacturers. QFocus deploys modern supply chain analytics methods with AI/ML algorithms to help clients

• Enhance inventory management by foreseeing supply disruptions
• Obtain end-to-end visibility and address vendor risk management
• Manage production capacity and conduct KPI process tracking
• Quickly respond to quality issues using data—driven insights and reduce potential recalls

QFocus understands that industries such as medical & life sciences operate in highly regulated environments. With leverage our partner ecosystem to provide a slew of regulatory compliance services to drive continuous improvement and regulatory compliance of our clients:

• ISO 13485, ISO 14971 AND ISO 11135/11137audit support
• Supplier Qualification Management (SQM)
• CSA validation assistance
• Safety and biocompatibility compliance support
• Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) analysis

Join QFocus Technologies to accelerate your medical and life sciences manufacturing goals at the highest levels of safety, quality and regulatory compliance.