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Medical Systems CONSULT

Medical Systems Consult is a leading consulting firm specializing in medical device development, regulatory compliance, risk management, FDA/EU regulations, and quality system implementation. Our team of experts can guide you through the full product lifecycle, from concept to market launch. We can guide you through the complex regulatory landscape, ensure compliance with the latest standards, and help bring your medical device to life. Contact us today to learn how we can assist with your product development needs.

Categories: Business, Business
Topics: digital therapeutics, eu mdr, fda, medical device development, quality system implementation, regulatory compliance, risk management, samd

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ivyworks.net
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510(k) – Premarket Notification for Medical Device aka PMN
AADA – Abbreviated antibiotic drug application
ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
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CCDS – Company core data sheet
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CDSCO – Central Drug Standard Organization (India)
cGLP – Current good laboratory practice
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Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
CPP – Certificate of pharmaceutical product
CQA – Clinical quality assurance
CR – Controlled release
CRO – Clinical Research Organization
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
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CTD – Clinical Trials Directive
CTD – Common technical document/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
CVM – Center for Veterinary Medicine (US)
DACS – Detailed and critical summary
DAE – Discontinuation due to an a

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