Quality Made Easy is in 2010 opgericht door Lydia Kluver.
Na ruim 30 jaar voor diverse werkgevers werkzaam te zijn geweest heeft zij besloten om zich zelfstandig te gaan vestigen.
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Medische Hulpmiddelen
MDR, EU verordening van 5 april 2017 betreffende medische hulpmiddelen
In Vitro Diagnoctics
IVDR, EU verordening van 5 april 2017 betreffende medische hulpmiddelen voor In Vitro Diagnostiek
Begeleidende documenten Medische Hulpmiddelen en IVD (MEDDEV)
2.1 Scope, field of application, definition
MEDDEV 2.1/1 Definition Medical Devices, Accesoiries and Manufacturer
MEDDEV 2.1/2 Application of the Active Implantable Device Directive 90/385/EC
MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators
MEDDEV 2.1/3 Borderline, drug-delivery products and med. devices incoporating medicinal substances or human blood derivative
MEDDEV 2.1/4 Demarcation between MDD, EMC and PPE directives
MEDDEV 2.1/5 Medical Devices with a measuring function
MEDDEV 2.1/6 Quantification and classification of stand alone software
2.2 Essential requirements
MEDDEV 2.2/1 EMC requirements
MEDDEV 2.2/3 "Use by" date
MEDDEV 2.2/4 Conformity assessment of IVF and ART products
2.4 Classification of Medical Devices
MEDDEV 2.4/1 Classification of medical devices
2.5 Conformity assessment procedure
MEDDEV 2.5/3 Subcontracting - Quality Systems related
MEDDEV 2.5/5 Translation procedure
MEDDEV 2.5/6 Homogeneous badges
MEDDEV 2.5/7 Conformity assessment of breast implants
MEDDEV 2.5/9 Medical Devices containing rubber latex
MEDDEV 2.5/10 Guideline for Authorized Representatives
2.7 Clinical investigation, clinical evaluation
MEDDEV 2.7/1 Clinical evaluation
MEDDEV 2.7/2 Guide for competent authorities in making an assessment of clinical investigation; notification
MEDDEV 2.7/3 Clinical investigations; serious adverse event reporting SAE - reporting form
MEDDEV 2.7/4 Clinical investigation
2.10 Notified bodies
MEDDEV 2.10/2 Designation and monitoring of notified bodies
2.11 Products using materials of biological origin
MEDDEV 2.11/1 Risk management is animal tissue products susceptible for TSE
2.12 Market surveillance
MEDDEV 2.12/1 Guidelines on a Medical Devices vigilance system
MEDDEV 2.12/2 Post market clinical follow up studies for Medical Devices
2.14 In Vitro Diagnostics
MEDDEV 2.14/1 IVD Medical Device borderline and classifications issues
MEDDEV 2.14/2 IVD products for research use only
MEDDEV 2.14/3 Supply of instructions for use and other information for IVD
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD
2.15 Others
MEDDEV 2.15/2 Committees/Working Groups for the implementation of the MDD