Quality strategies

Creating a well-defined and measurable quality strategy is very important right at the start of a company’s operational lifetime. It gives a solid base in developing company's processes as the business grows. A functioning quality system helps to establish customer confidence in the quality of the work being done within the company. Quality assurance guarantees the optimal results in producing products and services according to all requirements. Correcting a deviation in quality is always more cost-effective and easier if the deviation is found at an early stage. Quality assurance must be a high priority function from the start. The services we offer are:

• Quality audits
• Analysing and describing different processes
• Risk analysis and control
• Planning corrective and preventive actions

Validation programs

Well-defined and structured validation programs ensure that the company’s products, premises, devices, information systems and production processes are secure and reliable in their function. Different test patterns are used to validate processes, products, devices, areas or systems to ensure the functions according to pre-defined criteria. Validation is a tested, documented and approved proof of the reliable and consistent function of a process, method, area, device or system. The services we offer for validation are:

• Validation master plans
• Validation plans
• Validation reports

Regulatory authorities

The requirements of the various regulatory authorities must be considered and fulfilled in areas such as the marketing of medical devices, building quality systems, and the special requirements for clean rooms/clean areas. The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products and medical devices and products that give off radiation. Most of the manufacturers of medical devices must fulfill the requirements of the Quality System Regulation 21 CFR 820, even if the certification is not needed or given. GMP guidelines have been created to specify the GMP regulations and technical standards. The international ISO clean room/area standards give specified guidelines concerning the performance and technical requirements of the rooms and areas. We have a thorough experience of the requirements and regulations of the different authorities and are well-equipped to attend to all of the detail relating to them:

•  FDA: QSR   •   GxP (GMP, GLP, GAMP, jne.)   •   ISO9001, ISO14001 and ISO13485   •   CE-marking