Quality Systems Management

Archimedic is ISO 13485 certified. We deploy our SOPs and templates for your use, but this does not mean that your company is ISO 13485 certified by affiliation. In order to gain this certification you must register with a notified body and show evidence of compliance with your quality system and the applicable standards. The QSIM program puts many of the foundational pieces of ISO 13486 compliance in-place, but there are additional steps that will be needed to gain certification. 

No. Quality records, such as design controls and risk management documentation are outputs of the design process. If you contract Archimedic to complete development projects, then this project work will include generation of the applicable quality records. Conversely, your team may generate these quality records directly. QSIM will manage this documentation and conduct the audits to ensure that procedures are being followed, but QSIM does not include the generation of design controls and other project-related quality records..

Archimedic's QMS currently excludes regulatory filings, clinical investigations, post market surveillance and regulatory reporting of complaints and filed actions. Most of these activities are downstream of the typical quality activities needed by early stage medical device companies. Archimedic may expand QSIM to include these activities to meet customer needs, but they are currently considered out of scope of our QMS.

QSIM is billed as a monthly fee. This fee includes access to Archimedic's ISO 13845 quality management system standard operating procedures (SOPs) and templates. Additionally, it includes an allotment of quality systems management time, which is based on your company's needs.