Quality assurance
Companies that want to start a regulatory development course must establish a quality system and Standard Operating Procedures (SOPs) for all the company’s processes and methods. SurViva has expertise within quality assurance and assists companies in establishing a quality management system (QMS) that is required when moving from the early laboratory research to structured development.
Companies developing Medical Device (MD) will need the first components of a QMS already during planning of product realisation and must be certified according to ISO 13485 and Medical Device Regulation (MDR) before going to the market. We can assist with this path and provide training and support in connection with audits both internally and externally.
Quality assurance
Companies that want to start a regulatory development course must establish a quality system and Standard Operating Procedures (SOPs) for all the company’s processes and methods. SurViva has expertise within quality assurance and assists companies in establishing a quality management system (QMS) that is required when moving from the early laboratory research to structured development.
Companies developing Medical Device (MD) will need the first components of a QMS already during planning of product realisation and must be certified according to ISO 13485 and Medical Device Regulation (MDR) before going to the market. We can assist with this path and provide training and support in connection with audits both internally and externally.