Turning complex quality and compliance requirements into clear, actionable pathways.
As IRCA-certified auditors, we are capable of taking on internal auditing responsibilities, as well as performing your external audits of suppliers & customers. We can also perform mock audits of your technical documentation prior to submission.
Simplimedica is also very well experienced in remediating documentation where external audits have caused nonconformances or CAPAs.
25+ Years of Regulatory Experience
As IRCA-certified auditors, we are capable of taking on internal auditing responsibilities, as well as performing your external audits of suppliers & customers. We can also perform mock audits of your technical documentation prior to submission.
Simplimedica is also very well experienced in remediating documentation where external audits have caused nonconformances or CAPAs.
We have implemented dozens of ISO 13485 QMS Systems and can quickly have you up and running from scratch with a fully compliant system. We will also take care of all communications with notified bodies and manage the audits for delivery of your ISO certificates.
It is the manufacturer’s responsibility to ensure that there are adequate validation of all processes involved in the production of any of these products. We cater for equipment, cleaning and process validation, laboratory as well as test method validation.
Validating a process from beginning to end is a daunting task that can involve an entire trail of quality assurance, not only of the equipment involved in the production of your product but also of storage conditions. Process validation should verify that procedures and processes used in the manufacturing of your product, are suitable for their purposes and guarantee that the process used will consistently meet its predetermined specifications and quality characteristics. The procedure must outline the way of carrying out an activity. The process is a set of methods and actions which interact to convert what goes into what comes out.
Simplimedica has over 25+ years of experience with validations.
As part of managing your entire submissions, Simplimedica can ensure your design plan is in place and followed. We can project manage all elements of design & development, including inputs & outputs and ensure all verification and validation activities take place either with your capabilities of testing or we can use our strong network of providers, laboratories, and test facilities to ensure your physical, biological and chemical testing has satisfied the correct regulatory requirements to ensure your devices has met the safety characteristics needed.
