Device Development and Manufacturing
Procal’ s Research and Development Engineers are very creative and have been involved in development of various new design concepts for our medical device clients. Our engineers have been responsible for implementing lean and six sigma approaches in our client’s manufacturing facilities. They also work on continuous process improvements at our client’s site.
Quality System Implementation
All medical device-manufacturing companies in the US need to follow good manufacturing practices (GMP). Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation (QSR) of the 21 Code of Federal Regulations (CFR) Part 820. The FDA is responsible for monitoring the QSR compliance of all U.S. medical device companies.
Pharmaceutical Manufacturing and Validation
Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified.
ISO 14971:2007 or EN ISO 14971:2012 is an international standard for risk management of medical devices. The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management.
Procal technical operation team specializes in providing regulatory consulting services to their clients who are medical device manufacturers. We have a dedicated team working with our clients in regulatory strategy, preparation of FDA submissions, product manufacturing and testing, clinical trials set up and data collection and maintaining quality compliance.