The medical device industry is tightly controlled by regulatory requirements. The responsible manufacturer is obligated to ensure that all activities meet regulatory requirements – whether they are carried out in-house or outsourced to suppliers and distributors. Moreover, it is becoming increasingly common that a company expands its operations by acquiring one or more other companies.
Failure to meet the requirements can be costly. Prior to an acquisition or change/extension of a supplier or distributor, the company should implement a corporate inspection called due diligence in order to collect and analyze information about the potential supplier, distributor, or the acquired company.
What Symbioteq can do
Symbioteq can support you by conducting a regulatory due diligence. We go through and analyze the company’s quality management system, technical product documentation, certificates, registrations, etc., and evaluate this information in light of your requirements and applicable regulatory requirements. Based on this analysis, we will issue a report that can be used as a basis for decision-making and/or support in your contract negotiations.
Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.