Regulatory Guidance

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Auth Rep CE Marking FDA Guidance Docs Translations Euro Distribution Library

European Union CE Mark Regulatory Hands-on Help 

CE Marking Rules for most Products / Devices are very similar

Follow the steps in the order below to determine your compliance route. If you need professional support and any stage request a quotation in the form below 
Statement of Claim or Intended Use: This can affect the Classification of your product against your competitor's!
European Directive :Select the correct Directive and check for Amendments effected by other later Directives or National Members' Legislation (Standing Orders)
Route of Conformity: Select which Annex/es are best for Your Product / Device & for your Organisation
Notified Body Selection: If your selected Directive requires you to appoint a Certification Body, then choose one whose Assessors have right Experience & Technical Knowledge for your Product / Device

How to select and when to use a Testing Laboratory
Declaration of Conformity We provide Free Guidance Templates and Free Review of your Declarations.

Technical Files: 

Content: What must be included, Ask for our Index
Product / Device Changes: How to manage device changes with annexes & cross references,
New Products / Devices: How to create Product Families and when to inform your Certification Body

Quality Manual Drafting New or Re - writing your existing Q.M.S.

Electronic versions provided by M Devices Group
Joint compliance with the European Directive/s
EN/ISO9000 - 2000, 
EN46000 and other appropriate ones
Joint Compliance with FDA cGMP and other International Requirements. (Japan, China, Eastern Europe & others).

Procedures - Improving your exiting SOP's or providing New Procedures electronically integrated into your Quality Manual Guidance on Site Work Instructions.

How to beat the 4 most common Major Category 1 Failures identified by Certification Bodies

Risk Analysis: 1 Day training provided to your design engineers in Risk Analysis customised to your devices. 
Design Control: Best Practice - Easy ways to manage & control 
Clinical Evaluation: When not to do Clinical Trials.
Biological Evaluation of materials.

 Standards Suitability Review:  

Which standards to select and how to apply them in order of established hierarchy

Software Verification & Validation: including  & EMC compliance

Essential Requirements with Real Hands on help to correctly complete your ER Checklist Table

Sterilisation & Microbiology: 

ETO, Gamma or Steam.
Selecting the Right Process & contractor
Help with Sterilisation Validation
Analysing the Laboratory Test result

Clinical Evaluation and Clinical Trials 

When Evaluation is sufficient & when a Study is required
Preparing the Protocol
Managing the Study
Clinical Review, Analysis & Conclusion (Making the case) 

Vigilance Systems:  

How to implement post-production monitoring
How to implement Incident & Near Incident reporting & 
Help with implementing product recall systems
Management Review & Statistical Techniques: We provide templates & practical advice

Internal Auditing: 1 Day at your premises training for your audit team in how to achieve auditing compliance with your Relevant European Directive/s

Technical File Reviews: We review your Technical Files before applying your CE Mark or submitting to your Certification Body 
CompTechnical File Reviews: We review your Technical Files before applying your CE Mark or submitting to your Certification Body 

 

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Last modified: May 23, 2003