We are dedicated to service excellence, and we remain persistent in our commitment to innovation, quality, and compliance. Our Operating Business Units (OBUs) live up to the highest quality standards, allowing us to manufacture within various segments globally.
In August 2023, our electronics factory in Bangkok, Thailand, was certified with the FDA audit (Food and Drug Administration), establishing us as a reliable manufacturer of medical devices. The FDA – a US medical standard for medical devices – is a requirement for one of our customers in the MedTech segment. The medical audit guarantees that we are certified to follow the procedures and product requirements in the medical industry.
“Service excellence is at the heart of our business. We know the importance of thorough attention to detail and adherence to procedure. Achieving the FDA inspection requires a comprehensive understanding of the regulatory landscape and a commitment to meeting strict requirements. From data validation to critical software validation, every aspect of our manufacturing process is carefully inspected to ensure compliance with the ISO 13485 standard and US FDA 21 CFR Part 820 regulations,” says Ville Pirila, Vice President, Quality and HSE, at GPV.
The FDA inspection process
Throughout the entire organisation, our OBUs are able to manufacture products for customers because of our high-quality standard and the audits and certifications we obtain. The medical audits are strict and pays extensive detail to data validation.
The FDA inspection is an official examination of a facility to determine its compliance with the laws enforced by the FDA. The US FDA inspector focuses on every detail in our QMS document, also software validation and GMP (Good Manufacturing Practice). GMP refers to e.g. line clearance, ESD personal control and dressing discipline.
The validation process consists of
- IQ (Installation Qualification): A documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist.
- OQ (Operation Qualification): Test of the equipment, making sure it performs as specified, within operating ranges as listed by the manufacturer. All aspects of the equipment receive individual testing and the tester documents the proper operation of each.
- PQ (Performance Qualification): Verification and documentation that all equipment is working within the accepted range as specified. All instruments are tested together according to a detailed test plan and must generate reproducible results.
The certification audit takes place every three years with surveillance audits every year in between.
The FDA QS is a compliance that outlines Quality System Regulations for medical device manufacturers who sell and import in the USA whereas the ISO 13485 certification is a voluntary quality standard, providing a framework for meeting medical device quality requirements in the international market.
Several of our OBUs are ISO 13485 certified. Get a full overview of all our certifications.
