Medical  Device  &  QA  Consultancy

SUMMARY of the  SUPPORT and ASSISTANCE that is part of our

AUTHORIZED REPRESENTATIVE PACKAGE.....

Covers both IVD's and MDD's

  - eg: In Vitro Diagnostic Medical Devices under directive 98/79/EC or General Medical Devices under directive 93/42/EEC

Unlimited Email help with any regulatory or Quality System issue;

Help to address issues / non-conformances raised by your Notified Body at an Audit

Labeling Issues

Unlimited help to ensure that your Labels, Packaging, Instructions For use, Product Inserts etc are fully compliant

Fair Fee Scale

Costs fixed for 3 years, to help with budgeting.

One fixed price quoted, irrespective of the number of Products that you register (Some AR companies implement a rising scale, increasing with the number of products that you have).

Other European Community Member Country Issues

(See this link for full list: http://www.mdqaconsultancy.co.uk/eea%20list.html

Assistance to meet any additional requirements imposed by individual member countries.

Registration / Notification of your Products in all 30+ EU member countries, where applicable.

Guidance on Language requirements for Labels and Instructions For Use etc.

Post Sales Issues

Full Assistance to implement Post Sales Procedures covering:

PRODUCT RECALL + ADVISORY NOTICE ISSUE + EFFECTIVE COMPLAINT HANDLING + VIGILANCE / ADVERSE INCIDENT REPORTING + SIGNIFICANT CHANGE NOTIFICATIONS (to your Notified Body or a Competent Authority)

Adverse Incident  / Vigilance Reporting / Recall / Advisory Notice Issue

Assistance / Guidance to set up a Reporting System to ensure your Company's Regulatory Compliance throughout all EU member countries.

Full Assistance to implement a Product Recall, in the unlikely event of one becoming necessary.

Full assistance to Issue Advisory Notices to the "Area of Supply", if necessary.

Own Brand Labeling (Private Labeling)

Guidance to facilitate a Third Party to Own Brand Label your products, where required.

Technical Files / Design files / Design Dossiers

Help and guidance to ensure that your documentation is compliant with the regulatory requirements.

Assistance to find the best form of words for your Declaration Of Conformity

Distributors and Sales and Marketing

Your distribution network plays a vital role in promoting your company and your products and in helping meet sales and marketing targets.

Your distributors are also an important part of your regulatory compliance, as they provide a vital interface between you (the OEM) and the End Users of your products. As they therefore play an important role in Complaint Handling, Product Recall and Incident Reporting, your Authorized Representative can ensure that your Distribution network is fully effective in helping you meet your regulatory responsibilities.

Communication with the Regulatory Authorities

Your Authorized Representative is an important part of your regulatory compliance and can communicate with Notified Bodies and Competent Authorities on your behalf, as necessary.