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International market leader in the pharmaceutical industry

CER_FETTE
Fette Compacting

market

Europe

industry

Machinery

time to market

6 weeks

services

CE Certification

The Challenge

The international market leader of tablet presses in the pharmaceutical industry, Fette Compacting, reached out to us. They were in the engineering phase of a new machine and needed help constructing the technical file and executing the risk assessment in Safexpert (a risk-analysis tool).

Our Solution

We assisted, trained and guided Fette Compacting all throughout this project so they could execute all the required steps in Safexpert.
»With a highly versatile team, we offer product compliance solutions globally for SMEs to large companies.«
Ferry van Bergen-Henegouw
Certification Engineer

The Outcome

A new wayforward for the Fette Compacting team in which they ensure a higher level of safety of their operators.

Fette Compacting

A new wayforward for the Fette Compacting team in which they ensure a higher level of safety of their operators.
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Full-service product compliance without the headaches.

Leave it to us.

Information Supply

We notify you if there are regulatory changes pertaining to your product

Technical File

We ensure the availability of the technical file in case of requests from authorities

Legal point of contact

We represent you on your behalf for all legal issues pertaining to your product

EU/UK Market Access

You gain access to the EU/UK market, no matter where your business is located

Authorised Representative

We register as your official point of contact for market surveillance authorities

CE/UKCA Marking

Trust us as your partner to verify the compliance of your products

Expert Consulting

With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.

  • Product Compliance
  • Authority letter (NVWA, NoBo, ILT and BPT)
  • Authorised Representative
  • Product Testing
  • Seller/buyer problem resolution on CE marking
  • Advise on Product Legislation
  • User Information
  • Route to compliance
  • Engineering Review
  • Training
  • Risk Assessment
Training

We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.

  • Product Compliance
  • CE Marking
  • Machine / Robotics Safety
  • UL/CSA
  • Safexpert
User Information Review

Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.

  • Checklists
  • Product labelling
  • Templates
  • Drafting Manuals
  • Machine plate
Risk Assessment

We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.

  • Machine / Electronics / Toys / Medical / PPE / GPS
  • EN-ISO 12100
  • Safexpert Risk Assessment software (TÜV-certified)
  • Review of existing Risk Assessment
  • Templates
Route to compliance

We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.

  • Determining product legislation
  • Set up test procedure (in-house/accredited testing)
  • Strategy on Global Market Access
  • Technical File Checklist
Testing and Inspection

Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.

  • EMC, Low Voltage, Radio, Medical, Toys, and PPE
  • On-site or digital inspections
  • Notified Bodies
  • Accredited testing laboratories
Engineering Review

We review your designs and assist you through the prototype phase to ensure critical safety standards are met.

  • Design Review
  • Co-engineering
  • Consultancy
  • Risk Assessment
Technical File

Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.

  • Declaration of Conformity
  • User Information (manual/labelling/packaging)
  • Risk Assessment
  • Technical schemes and drawings
  • Templates
Authorised Representative

We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.

  • EU/UK market access
  • Verification of CE/UKCA
  • Marking
  • Contact point for authorities
  • Technical File
  • Bypass importers
  • Registration
Compliance

Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.

  • Consultancy
  • Route to compliance
  • Testing
  • On-site inspections
  • Design Review
  • Technical File Review
  • Risk Assessment
  • Training