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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
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 Statement of Claim or
Intended Use: This can affect the Classification of your product against your
competitor's!
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| European Directive :Select the correct Directive and check for
Amendments effected by other later Directives or National Members'
Legislation (Standing Orders)
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| Route of Conformity:
Select which Annex/es are best for Your Product / Device & for your
Organisation
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| 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. |
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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
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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).
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Procedures
- Improving your exiting SOP's or providing New Procedures
electronically integrated into your Quality Manual Guidance on Site Work Instructions.
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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.
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Standards
Suitability Review:
- Which
standards to select and how to apply them in order of established
hierarchy
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Software
Verification & Validation: including
& EMC compliance
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Essential
Requirements with Real Hands on help to correctly complete your ER
Checklist Table
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Sterilisation
& Microbiology:
- ETO,
Gamma or Steam.
- Selecting
the Right Process & contractor
- Help
with Sterilisation Validation
- Analysing
the Laboratory Test result
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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)
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Vigilance
Systems:
- How to implement
post-production monitoring
- How
to implement Incident & Near Incident reporting &
- Help
with implementing product recall systems
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| Management
Review & Statistical Techniques:
We provide templates & practical advice
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Internal
Auditing: 1 Day at
your premises training for your audit team in how to achieve auditing
compliance with your Relevant European Directive/s
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Technical
File Reviews: We review
your Technical Files before applying your CE Mark or submitting to your
Certification Body
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| CompTechnical
File Reviews: We review
your Technical Files before applying your CE Mark or submitting to your
Certification Body |
