CE MARKING AND UKCA MARKING GUIDANCE
REGULATING MEDICAL DEVICES IN THE UK
THE MEDICAL DEVICES REGULATIONS (2002)
DIRECTIVE 90/385/EEC - ACTIVE IMPLANTABLE MEDICAL DEVICES
DIRECTIVE 93/42/EEC - MEDICAL DEVICES
DIRECTIVE 98/79/EEC - IN VITRO DIAGNOSTIC MEDICAL DEVICES
GUIDANCE ON THE REGULATION OF IVD MEDICAL DEVICES IN GB
APPLYING FOR A MANUFACTURER OF MEDICINES LICENSE
REQUIREMENTS FOR SITE MASTER FILES
FDA MEDICAL DEVICE EXEMPTIONS
FDA DEVICE REGISTRATION AND LISTING
FDA GUIDANCE ON DESIGNATING A US AGENT
FDA INVESTIGATIONAL DEVICE EXEMPTIONS (IDE)
FDA QUALITY MANAGEMENT SYSTEM REGISTRATION (QMSR)
FDA DEVICE LABELLING REQUIREMENTS
FDA MANDATORY REPORTING
ISO COUNTRY CODES LIST
ISO 13485:2016 MEDICAL DEVICES (PREVIEW)
IEC 62304:2006 MEDICAL DEVICE SOFTWARE (PREVIEW)
ISO 15189:2022 MEDICAL LABORATORIES (PREVIEW)
ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEMS (PREVIEW)
ISO 26000 SOCIAL RESPONSIBILITY (FULL GUIDANCE)
ISO 31000:2018 RISK MANAGEMENT (PREVIEW)
THE PATENTS ACT (1977)
THE COPYRIGHT, DESIGNS & PATENTS ACT (1988)
IMPERIAL INTELLECTUAL PROPERTY POLICY
IMPERIAL RESEARCH PUBLICATIONS OPEN ACCESS POLICY
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IMPERIAL GUIDELINES FOR PROPER SCIENTIFIC CONDUCT IN RESEARCH POLICY
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IMPERIAL FINANCIAL REGULATIONS POLICY (RELATED TO IMPERIAL BRAND IDENTITY AND USAGE)
MARKET ACCESS IN GREAT BRITAIN
NICE FOR MARKET ACCESS TO THE NHS
POST-MARKET SURVEILLANCE - EXCEPTIONAL USE AUTHORISATION
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