Our Expertise
The medical device industry is a critical driver of healthcare innovation, leveraging advanced technologies, embedded systems, and rigorous regulatory frameworks to improve global well-being. At Staftonic, we understand the sector's multifaceted challenges and provide bespoke staffing solutions to address its unique needs. From pioneering R&D to optimizing GMP-compliant manufacturing workflows, we connect organizations with specialized expertise to thrive in this dynamic field.
Key Areas of Expertise
Embedded Systems and Software Development
Engineers proficient in developing firmware, working with RTOS (Real-Time Operating Systems), and programming in embedded C/C++, ensuring high-performance functionality and seamless integration of devices.
Design and Engineering
Specialists experienced in CAD platforms like SolidWorks and AutoCAD, utilizing FEA (Finite Element Analysis) for stress-testing, and performing rapid prototyping with 3D printing technologies.
Manufacturing and Production
Professionals skilled in implementing GMP (Good Manufacturing Practices), DFMA (Design for Manufacturing and Assembly), Six Sigma methodologies, and automation technologies like PLCs and SCADA systems for production optimization.
Auditing and Compliance
Experts with proficiency in conducting internal audits, performing gap analysis, and executing CAPA (Corrective and Preventive Actions) to ensure adherence to standards such as ISO 13485:2016.
Process Development
Specialists in process mapping with tools like Visio, workflow optimization using Lean Six Sigma, and continuous improvement strategies guided by Kaizen principles.
Post-Market Surveillance
Talent equipped to handle MDR (Medical Device Regulation) vigilance reporting, adverse event tracking, and trend analysis for effective market monitoring and compliance.
Regulatory Affairs and Compliance
Professionals experienced in FDA 510(k) premarket submissions, handling EU MDR documentation, and ensuring compliance with ISO 14971 for risk management protocols.
Quality Assurance
Experts in IQ/OQ/PQ validations, thermal and mechanical testing, and quality systems management adhering to ISO 9001 and ISO 13485 standards to maintain uncompromised product integrity.
Supply Chain and Logistics
Specialists skilled in ERP systems like SAP and Oracle, implementing advanced demand forecasting models, and overseeing cold chain logistics for temperature-sensitive devices.
With a focus on embedded innovation, compliance, auditing, and process optimization, Staftonic empowers businesses in the medical device industry to achieve their goals and deliver impactful healthcare solutions. Partner with us to elevate industry benchmarks and shape the future of medical technology.