Testing laboratory and consultancy · Granges-Paccot

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CE marking · Certification plan

Certification plan

Before you develop or test, you need to know where you are heading. We analyse your product, its application and its technologies, then propose the most suitable certification path: applicable legislation, harmonised standards, tests and requirements to plan for, costs and timeline. You know exactly what lies ahead before committing your budget.

Functions, application, technologies
Product
Regulations and harmonised standards
Legislation
Requirements and tests to plan for
Testing
Estimated costs and timeline
Budget

Who it is for

You are preparing to place a product on the market

  • Start-ups

    A first product: build compliance in from the prototype stage and cost the certification for your funding plan.

  • SMEs

    A new product or a new version: know what changes, what can be reused and what needs to be planned.

  • Large corporations

    A new market or a new technology: radio, software, battery, laser, cybersecurity.

  • Importers and distributors

    A product to import: check what the manufacturer must provide and what remains your responsibility.

What the plan contains

Your certification path, step by step

The plan starts from your product, not from a list of standards. It tells you what to do, in what order, at what cost and how long it will take.

An engineer and a designer analyse an opened product on the workbench
Product analysis

Understanding your product

What does your product do, for whom and in what environment? Power supply, radio, software, moving parts, laser, battery: we analyse its functions, application and technologies with your teams, because that is what determines everything else.

What you receive

  • Description of the product and its intended use
  • Technologies, variants and target markets
  • Open questions to be resolved
Consultant and engineers reviewing regulatory documentation
Applicable legislation

Regulations and harmonised standards

Low voltage, EMC, radio equipment, machinery, medical devices, Cyber Resilience Act: we identify the EU and Swiss legislation that applies to your product, then the harmonised standards that can be used to demonstrate conformity, with their editions and their status in the Official Journal.

What you receive

  • Applicable legislation, EU and Switzerland
  • Harmonised standards and editions to apply
  • Conformity assessment procedure, with or without a notified body
Engineer preparing a test on an opened electronic device
Tests and requirements

Preparing the tests and requirements

Which tests, on which samples, at what stage of development? We list the design requirements to build in early and the tests to carry out, and pinpoint the risk areas to check with pre-compliance tests.

What you receive

  • Design requirements to build in
  • Test programme and samples required
  • Risk areas to check early
Engineer presenting a project timeline to two clients
Costs and timeline

Estimating costs and timeline

How much will certification cost and how long will it take? We estimate the budget for testing, documentation and, where required, the notified body, and build a realistic timeline aligned with your launch date.

What you receive

  • Cost estimate per step
  • Certification timeline
  • Options to reduce costs and lead times

What comes next

Why start here

Prepare for certification instead of being caught out by it

A certification plan costs little compared with redesigning an enclosure or repeating a series of tests.

  • No surprises at the end of the project

    A requirement discovered after industrialisation means a new circuit board, a new enclosure or a new series of tests. The plan brings these to light from the outset.

  • A budget under control

    You know the cost and duration of certification before committing your resources, and can build them into your development and funding plan.

  • The right tests, done once

    Tests are scheduled on representative samples, at the right stage of development, with pre-compliance tests wherever the risk of failure is high.

Our approach

How a certification plan works

  1. Discovery call

    Your product, your markets and your timeline. 30 minutes.

  2. Analysis

    Documents, schematics, prototype: we study your product with your teams.

  3. Drafting

    Legislation, standards, procedure, tests, costs and timeline in one clear document.

  4. Presentation

    Presentation of the plan, answers to your questions and next steps.

Swiss market

One plan for Switzerland and the EU

In Switzerland, the Product Safety Act (PrSG) and the sector-specific ordinances largely adopt EU requirements, and the Switzerland–EU Mutual Recognition Agreement (MRA) often allows the same technical file to be used for both markets. This is not always the case: medical devices, for example, have been subject to separate rules since 2021. The plan sets out what applies on each market.

Sources: Swiss Product Safety Act (PrSG), SR 930.11; Swiss Medical Devices Ordinance (MepV), SR 812.213, Article 51.

Frequently asked questions

Frequently asked questions about the certification plan

Preparing a product? Talk directly to an engineer.

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What is a certification plan?

It is the roadmap for bringing your product into compliance: the legislation that applies, the standards to use, the conformity assessment procedure, the design requirements, the tests to carry out, and the estimated costs and timeline. It lets you make informed decisions before committing the certification budget.

When should a certification plan be drawn up?

As early as possible, ideally before the first prototype: safety, EMC and cybersecurity requirements have a direct impact on design. It remains useful later on, for example before starting the tests, targeting a new market or modifying an existing product.

What do you receive at the end?

A clear document listing the applicable legislation and standards, the procedure to follow, the requirements to build in, the test programme, the cost estimate and the timeline, together with any questions still open. We present it to you and answer your questions.

Does my product need a notified body?

It depends on the legislation and often on the class or category of the product. Many electrical and electronic products do not: the manufacturer assesses conformity itself. Others, such as certain machinery, medical devices of class IIa and above, C1 to C3 class drones or certain radio products and toys, must go through one. The certification plan clarifies this for your product.

Sources: The ‘Blue Guide’ on the implementation of EU product rules, OJ C 247, 29.6.2022

Does the plan cover Switzerland?

Yes. For each requirement, we indicate what applies in the EU and in Switzerland, where the rules are similar but not always identical: for example, a Swiss authorised representative for medical devices, or separate ordinances for toys and drones.

Sources: Swiss Product Safety Act (PrSG), SR 930.11; Swiss Medical Devices Ordinance (MepV), SR 812.213

Can you then carry out the tests and the technical file?

Yes. The certification plan is the basis for the rest of the project: risk assessment, laboratory testing, technical documentation and EU declaration of conformity. You can also use it with your own teams.

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Tell us about your product

Book a 30-minute slot with an engineer directly. No back-and-forth by email: you choose the time, we prepare the call.

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Contact details

Address
Säfeli Sàrl
Route d'Englisberg 3
1763 Granges-Paccot
Languages
French, German, English
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