Help with CE Marking Medical Devices, Drug Delivery, Electronic, Software, Invitro Diagnostic, Electrical & Personal Protective Equipment Products, just email paul@mdevices.net or call +44 7970 544 944 for urgent assistance

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INNOVATIVE PRODUCTS & SERVICES
M. DEVICES Ltd LAUNCHED A NEW DEVICE EVERY MONTH FOR SIX MONTHS
New Free Library Opening Soon Search Facility Available Click on the book above		VASCULAR LATEX FREE Embolectomy, Occlusion, Biliary, Bi-Lumen Distal/Proximal Catheters 100% Silicone & The Latest NEW Carotid Endarterectomy Shunt Double Balloon by Lucas Medical. NEW & IMPROVED SERVICES IMAGING & SOFTWARE SPECIALIST GUIDANCE - MDG's Technical Specialists lead the way in providing hands-on advice to organisations working at the leading edge in developing new medical software & imaging processes in the medical device, diagnostic & bio-genetics product sectors. Fast Tracking Regulatory CE Marking, including Clinical Investigational Trials & FDA Approvals. MDG's Technical Support includes working with multi-partner EC R&D Funded projects. IMPROVED AUTHORIZED REP SERVICE Includes EU Representative Services for Medical Devices, In-Vitro Devices, PPE (Personal Protective Equipment) & Electrical Medical Equipment. See our New Standards Advisory Service, which keeps you up to date with Amended & New Directives & Standards. NEW REGULATORY GUIDANCE LIBRARY TO BE ADDED IN EARLY 2003 - FREE DOCUMENT SEARCH & RETRIEVAL ESSENTIAL REQUIREMENTS & RISK ANALYSIS MODELS TO BUY

REGULATORY ADVICE HANDS-ON-HELP

Medical Devices, Drug Delivery Devices, In-Vitro Diagnostics & Medicines,

Note change of name for UK Competent Authority from Medical Devices Agency to Medicines & Healthcare Products Regulatory Agency
Human & Animal Tissue / Organs, Gene Therapy, Software, Electrical, Cardiovascular, Vascular, Neurology, Radiography (Including Radioactive Isotopes), Wound Management, ASD, PDA, Occluders and many other specialist areas.

MHRA Open Consultation on the Medical Devices Amendment Regulations 2003
On 1 April 2003 manufacturer's of medical devices were invited to comment on the proposed changes to the Regulations covering the manufacture and supply of such products. These are due to come into force in the UK from 1 August this year. The MHRA are transposing into UK Law Directive 2003/12/EC on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices. The MHRA are also intending to transpose the Commission Directive concerning medical devices incorporating tissues or derivatives originating from animals.

Competent Authorities Meeting for Medical Devices, Athens, 16-17 January 2003

Safety concerns presented by medical software

The meeting discussed an analysis of medical software incidents. The meeting agreed to establish a Working Group with industry participation under the Medical Devices Expert Group (MDEG) to take forward this important public health issue. The Competent Authorities (CAs) concluded that this significant subject might usefully be elaborated further during the E.U. chairmanship of Global Harmonization Task Force (GHTF) commencing in January 2004.

All Classes of Devices for Europe, Eastern Europe, USA & Canada, Japan, Australia, & Middle East. FREE copy of 93/42/EEC


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New Parcel Tracking System introduced: -
Track you parcels anywhere in the world or even just in the UK & Eire. Our dispatch dept will email or fax you your tracking number when we ship your devices. You can then track your delivery by the Internet. Click on either:

NEWS & TOPICAL ITEMS

CHINA STORIES -- Stories of China to follow soon and many pictures of the wonderful friends we made and places they took us to .

Essential Requirements & Risk Analysis Models to Buy
As part of Distant Learning Programs we now offer easy to use models to instruct you through the process of completing your Essential Requirements Checklist and Also your Risk Analysis

MDG taken on by Sorin Biomedica S.p.A to fast track the opening up of the UK market for Peripheral, Infrapopliteal & renal Coated Stenting
Target New Centres of 1 every week be surpassed. If you have an Innovative Radiology Product and want to introduce it to the UK & Eire market call paul: