Process & Product Validation
Medical Device Process Validation
Medical Device Process Validation
Bringing a medical device to market requires more than innovation: it demands absolute confidence that every process and product meets the highest standards for safety, quality, and regulatory compliance.
At Harmac, we approach Process & Product Validation with one goal: to ensure that each product we manufacture performs consistently and safely, meeting both patient needs and global regulatory requirements from the very first unit to the last.
How We Help
Our validation process begins at the design stage and continues throughout the entire product lifecycle
Every process is rigorously analyzed and controlled to ensure that production consistently delivers products that meet strict quality specifications. With our comprehensive medical device validation procedures in place, customers have the assurance that Harmac’s manufacturing processes are carefully managed, fully documented, and capable of reliably producing safe, effective devices.
Using a Risk Analysis Approach
At the core of our validation approach is risk analysis. Using Failure Mode Effect and Criticality Analysis (FMECA), we identify potential risks early and implement targeted mitigation strategies.
This proactive method helps speed new and innovative products to market – particularly those addressing unmet medical needs – while maintaining patient safety and regulatory compliance as top priorities. Our deep expertise in process validation enables us to help customers navigate complex regulatory environments and meet evolving industry expectations with confidence.
Medical Product Compliance
Our company’s validation practices are fully aligned with global standards, including FDA Quality System Regulation (21 CFR 820) and ISO 13485 Quality Management Systems for medical devices. This ensures that every product we manufacture not only meets but often exceeds the requirements set by regulators worldwide.
Comprehensive Validation Process
As part of our comprehensive validation master plans, Harmac follows a proven framework to ensure consistency, control, and long-term process stability. This includes:
- Installation Qualification (IQ), confirming that equipment and systems are correctly installed and capable of performing required operations
- Operational Qualification (OQ), verifying that equipment operates as intended across all conditions
- Performance Qualification (PQ), demonstrating that processes reliably produce products within established specifications.
- Process Performance Qualification (PPQ) is also employed to assess and control sources of variability, ensuring that the process remains stable and predictable throughout production.
- Test Method Validation (TMV) to confirm that our testing methods consistently differentiate between acceptable and unacceptable product units.
- Measurement System Analysis (MSA) to verify the accuracy and reliability of all measurement tools and methods used during production. These measures ensure data integrity, process stability, and long-term product performance.
At Harmac, Process & Product Validation is a commitment to delivering safe, reliable, and effective medical devices to patients who depend on them every day.
Let’s work together
No matter where you are in your manufacturing process, we can help. If you need direct access to our engineering team, you are in the right place.
