Manufacturing Services

Efficient and compliant manufacturing processes are at the core of producing safe and effective medical devices that meet global regulatory standards. Manufacturers must adhere to strict guidelines set by regulatory bodies like the FDA, ISO 13485, and the EU MDR to ensure that every aspect of production, from design transfer to final product release, is controlled and validated.

Our manufacturing services cover the entire product lifecycle, providing support from the initial design phase through to ongoing process validation and continuous quality improvement. We assist with design transfer, ensuring that all design inputs are accurately translated into production specifications. During this critical phase, we help establish robust processes that ensure the product is manufactured consistently to meet both quality and regulatory standards.

Process validation is a key element of our manufacturing services. We help manufacturers create and implement validation plans for essential processes like sterilization, packaging, and environmental control. By validating these processes, manufacturers can ensure that their production systems consistently produce products that meet predefined specifications. This reduces the risk of product recalls, non-conformance, and delays in bringing the product to market.

In addition to process validation, our services include ongoing monitoring and control of manufacturing processes. We provide statistical process control (SPC) to ensure that variations in production are kept to a minimum and that products consistently meet quality requirements. Our experts also assist with supplier audits and qualification, ensuring that the entire supply chain meets regulatory expectations. With increasing global regulations, supply chain management has become an essential part of maintaining compliance, and we work with you to ensure your suppliers meet the same high standards.

For manufacturers looking to scale production, introduce new products, or streamline operations, we offer lean manufacturing support. Implementing lean manufacturing principles helps reduce waste, lower production costs, and improve overall efficiency. Our team helps identify areas for improvement and works with your team to implement cost-effective, compliant solutions. This not only improves operational efficiency but also ensures that products meet regulatory standards at every stage of production.

We also support manufacturers in managing process changes, ensuring that any modifications to the manufacturing process are properly documented and compliant with regulatory requirements. By maintaining a proactive approach to process control and validation, manufacturers can avoid costly errors and remain compliant with evolving global regulations. From initial production setup to ongoing quality management, we help you create a robust manufacturing process that delivers high-quality medical devices.

Our manufacturing services include:

• Design transfer and scale-up: Seamlessly transition your product from design to serial manufacturing, ensuring all processes are optimized for large-scale production.
• Process validation: Ensure that your manufacturing processes consistently produce compliant and high-quality products.
• Non-product software validation: Validate all non-product software systems used in the manufacturing process to maintain compliance and data integrity.
• Equipment qualification: Qualify your production equipment to ensure it meets regulatory and operational requirements for consistent performance.
• Environmental controls and maintenance: Maintain a controlled production environment that meets industry standards for cleanliness and safety, ensuring product quality.
• Supply chain management: Manage and oversee the entire supply chain, from raw material sourcing to final product delivery, ensuring compliance and traceability.
• Production preparation: Prepare your manufacturing lines for production, including setup, calibration, and readiness checks.
• Sterilization and packaging: Ensure your products are sterilized and packaged according to regulatory standards for safe shipment around the globe.
• Production and process controls: Implement production controls that ensure your manufacturing processes are reliable and consistent.
• Infrastructure and work environment: Optimize your manufacturing infrastructure and work environment to meet regulatory and safety standards.
• Receiving and final inspections: Conduct thorough inspections at both the incoming materials receiving and final product release stages of production to ensure product quality and compliance.
• Monitoring and measurement of processes: Continuously monitor and measure production processes to identify areas for improvement and maintain product quality.
• Control of monitoring and measuring equipment: Ensure all monitoring and measuring equipment is properly calibrated and maintained for accurate results.
• Statistical methods (SPC/AQL): Apply statistical process control (SPC) and acceptable quality limits (AQL) to ensure that your manufacturing processes remain within required specifications.
• Purchasing controls: Establish purchasing controls to ensure all materials and components meet quality and regulatory standards.
• Audits and inspections: Prepare for regulatory audits and inspections by ensuring that all manufacturing processes are well-documented and compliant.
• Unique device identification (UDI): Implement UDI systems to ensure traceability and regulatory compliance of your devices.
• Service and maintenance: Provide ongoing device service and maintenance to ensure that your device continues to operate efficiently in the field and meets regulatory requirements.

We also support manufacturers in managing process changes, ensuring that any modifications to the manufacturing process are properly documented and compliant with regulatory requirements. By maintaining a proactive approach to process control and validation, manufacturers can avoid costly errors and remain compliant with evolving global regulations. From initial production setup to ongoing quality management, we help you create a robust manufacturing process that delivers high-quality medical devices.

We have compiled a list of articles and training courses on the issue of manufacturing to help you and your colleagues.

ISO 14971:2019 - Application of Risk Management to Medical Devices Overview
ISO 14971 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s QMS.

Understanding Top Management Responsibilities for Medical Device Quality Management Systems
Top management is not simply the most responsible corporate officials, but also those responsible for site-specific activities throughout the organization. When considering action, regulatory authorities may use a “wide net” when identifying top management. It is essential that top management of all levels of an organization understand its obligations to quality.