Compliance , Excellence and Productivity with peace of mind.
Say goodbye to endless QMS maintenance efforts with our Human Intelligence expertise combined with AI-enhanced approach.Compikal' s mission is to partner with its Medical Devices customers to provide productive, effective, and affordable Quality Management System that meets their business needs while focusing on patient safety.Compikal keeps your Quality Management System up-to-date so you can focus on building innovative Medical Devices.
Need to watch well-structured QMS ?View our curated QMS documentation of 60+ essential SOPs that comply with ISO 13485, QSR 820, ISO 14971, IEC 62304, EU MDR 2017/45 and Reporting standards.
Simply push Submit and apply for FREE view:
QMS Health Check - Up to improve readiness ?
Utilize our Compliance Radar
to pinpoint gaps & improvement opportunities Comprehensive with regard to ISO 13485, QSR 820, ISO 14971, Reporting, EU MDR, IEC 62304 or MDSAP.
Looking for productivity?Customizable SOPs and templates pre-built to comply with ISO 13485, QSR 820, ISO 14971, EU MDR 2017/45 and more for quick and easy adaptation.
Can be extended to additional standards like IEC 60601-1, IEC 62366 and more per your needs.
Why choose Compikal as your QMS partner ?The Perfect Blend of HI and AI .
Our solutions are practical to support your Compliance, Excellence and Productivity.Our current customers are threptic invasive and non invasive Electro- Mechanical Medical Devices Class II Start-Ups.
Our main product quality focus are: Patient Safety, Usability, Reliability and Supply Chain.Danny Even Chen is Compikal' s Customer Solutions leader, MD and IVDR industry veteran who understand your challenges.
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Quality Manual
Partial List of QMS SOPs and templates
SOP
Quality System Management
SOP
Corrective and Preventive action ( CAPA)
Legal Disclaimer and Terms of Use
Compikal provides quality management and regulatory consulting services to medical device companies. While we strive to ensure the accuracy and completeness of all information, advice, and documentation provided, we make no warranties or representations regarding their fitness for any particular purpose.
Customers are solely responsible for the implementation, adaptation, and use of any information, advice, or documentation provided by Compikal. It is the customer's responsibility to ensure all quality systems and documentation comply with applicable regulations, standards, and requirements specific to their products, intended markets, and organizational needs.
The information and documentation provided by Compikal are intended as guidance only and do not constitute legal advice. Customers should consult with qualified legal counsel regarding specific regulatory requirements applicable to their medical devices.
Compikal shall not be liable for any direct, indirect, incidental, consequential, or special damages arising out of or in connection with the use of our services, documentation, or advice, regardless of whether Compikal has been advised of the possibility of such damages.
By using Compikal's services, customers acknowledge and agree to these terms.
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