Engineering Services
Engineering Services Hub
Precision
At Novem precision at all processes are achieved through DOE in all manufacturing process during the process development, six sigma implementation and continuous process improvements during the life of the product
Expertise
Novem brings unmatched engineering knowledge to the table, with experts with more than 15 years on the medical devices manufacturing, that goes from quality assurance, medical regulatory compliance, manufacturing and process improvement, design and equipment development
Excellence
Novem's services, from design to production, embody excellence. Rigorous quality controls, custom solutions, and a relentless pursuit of perfection define our commitment.
Process Development Expertise:
At Novem, Process Management (development and improvement) focuses on creating efficient, effective and flexible systems to meet customer needs and remain aligned with the goals and objectives of the strategic plan. It is the work roadmap, aimed at building, maintaining and improving work processes through:
- Designing clear processes to manufacture products.
- Implementing steps to improve the efficiency of manufacturing.
- Integrating engineering and innovation into the development of products
- Monitoring and following regulatory requirements.
- Identifying cost-effective ways to produce products in larger quantities.
- Supervising production and quality control
- Re-evaluating processes and identifying areas of improvement
- Perform process characterizations studies.
- Keep abreast of current development and process technology trends in the field.
Process Development Expertise
Kaizen: Continuous improvement methodologies to enhance operational efficiency.
7S’s: Streamlining workspace for optimal productivity and organization.
Standard Work: Developing and implementing standardized processes for consistency.
TPM (Total Productive Maintenance): Maximizing equipment effectiveness to eliminate downtime.
SMED (Single-Minute Exchange of Die): Minimizing setup times for increased flexibility.
PDCA (Plan-Do-Check-Act): A systematic approach for continuous improvement.
At our Engineering Hub, we sculpt efficiency with Kaizen, set the standard with TPM, and navigate complexities with Quality System Consulting. From validating success to crafting blueprints of excellence, choose us for engineering that elevates precision and efficiency.
Quality Assurance & Regulatory Compliance
- Novem Medical is an ISO 13485:2016 certified manufacturer.
- Quality Management System adheres to Good Manufacturing Practices and Good Documentation Practices for production of medical devices FDA Class I, II and III.
- Novem Medical facilities are registered with the U.S. Food and Drug Administration.
- Novem Medical offers an ISO 14644-1:2015 Class 8 certified cleanroom for mass production of medical devices FDA Class I, II and III.
- We, at Novem Medical, are committed to Customer Satisfaction, providing products and services that exceeds the customer requirements through innovation and optimization of our processes, based on continual improvement in compliance with Medical Regulations to maintain the effectiveness of the quality management system.
Validation Services
At Novem Medical, our Quality System guidelines advise to verify that all our client’s products must meet the design specifications. For every new product introduction, we validate that the manufacturing process has proper controls to guarantee the production of devices meet specific customer/user needs and safety, regulatory, and technical requirements.
We offer:
- Process/Equipment Qualification. We use IQ/OQ/PQ Protocols to demonstrate the equipment being used will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements.
- Inspection Method Qualification . With a high percentage of confidence and reliability, we make sure all our client’s products are verified exactly and precise.
- R&D Testing to ensure the products and services are safe, reliable and of good quality for the patient, including functional specs, regulatory requirements, and user needs.
- Engineering Studies to assist our clients in design specifications and/or troubleshooting
- Statistical Evidence to prove that all the above is true!
Drafting Services
Our engineering support extends to precise and meticulous drafting services for comprehensive documentation.
Choose our Engineering Services Hub for a transformative partnership that ensures your processes are not just efficient but also compliant, validated, and future-proof. Contact us today to discuss how our expertise can elevate your engineering endeavors to new heights.
We specialize in:
- Product
- Equipment
- Tooling
- Production line