Who is QME

Lydia Kluver

Quality Made Easy was founded by Lydia Kluver in 2010.
After more than 30 years of experience, working for several employers, she decided to set up a company of her own.
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EU Directives and guidelines

 

Medical Devices

MDD 93/42/EEC

MDD 2007/47/EC

 

EU regulation 2017/745 on Medical Devices

MDR 2017/745

 

In Vitro Diagnoctics

IVD 98/79/EEC 

 

EU regulations 2017/746 on In Vitor Diagnostics Medical Devices

IVDR 2017/746

 

Guidance Documents Medical Devices and 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 


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