About
Drott Quality is a consulting company specialized in medical devices. We are dedicated to help our clients focus on the right things, and become efficient where knowledge within regulatory requirements are extremely important. Certified Lead Auditor from a Swedish Notified Body. Collaborations with small start-ups and large international companies. Regulations & standards: ISO 13485, MDR/IVDR, 14971, 62304, 62366-1, GMP • interim quality manger, QMS specialist, QA/RA support • QMS implementation • technical documentation compilation • regulatory submissions, CE marking/US • process development and improvements • auditing Contact info: [email protected] +46708290145
Technologies
Outlook
Mobile Friendly
Apache
Varnish
Keywords
510 clearance
regulatory affairs
ce mark
qara
quality assurance
iso 13485
medical device
qms
technical documentation
medical equipment manufacturing
standard operating procedures
management consulting
process development
medical devices
regulatory expert advice
external audits
audits
consulting
audit preparation support
iso standards
other scientific and technical consulting services
mdr 2017/745
medical technology
ce marking
quality management system
regulatory documentation
regulatory compliance
b2b
software development standards
life sciences
Company Information
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Employees 1
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Founded 2022
Location
Lund, Skane County, Sweden