Highly regulated industries engage us to develop and manufacture their automated equipment for manufacturing processes, testing and calibration because of our proven track record for developing unique and effective solutions, product development and quality engineering. We’ve earned the privilege to be included on the consolidated Approved Supplier Lists of several large medical device companies.
Our team of engineers ensure that your internal compliance and documentation needs are met. We complete onsite testing and validations. We maintain our own rigorous high standards for quality
The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably, and grow their business in an environment of increasing globalization and elevated product development costs. This is challenging enough in itself; but in market sectors such as medical device and biotech manufacturing, the task is even more daunting due to the additional burden of dealing with the various facets of manufacturing compliance originating from regulatory agencies like the FDA.
The core mandate guiding FDA regulatory oversight is consumer safety. As a result, the FDA has defined Good Manufacturing Practices (GMP) for both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to consistently produce safe, quality products.
Most clients prefer to create and execute their own protocols for Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ) or Product/Process Qualification (PQ). In other cases clients use our protocol templates to qualify the equipment.