Monitoring of Standards, Regulations, and Guidelines

Easy Setup to Start Monitoring

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Define your standards, regulations, and guidelines to monitor. PREXEVUS offers different ways of uploading and defining the standards.

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Organize the standards, regulations and guidelines per product, portfolio, site or for the entire company.

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Define the alerting intervall for daily, weekly, monthly or quaterly, and you are all done.

Choose from the simple configuration possibilities

CSV - Upload

Simply drag and drop your list of standards, regulations, and guidelines as a CSV into PREXEVUS. Done!

Expert Questionnaire

Answer a few questions and magically, all relevant standards, regulations, and guidelines are filled in.

Manually

Define all standards, regulations and guidelines manually by activating each individually.

We currently monitor the following

Standards

Up and running are:

  • ISO
  • IEC
  • ASTM
  • EN
  • U.S. FDA consensus standards
  • MDR / IVDR harmonized standards

Regulations

Up and running are:

  • U.S. FDA 21 CFR
  • Eur-Lex

Guidelines

Up and running are:

  • U.S. FDA Guidelines
  • European Commission Guidelines
  • MEDDEV Guidelines

See what we are working on

Drafting

Implementing

  • DIN Standards
  • IEEE Standards
  • VDI Standards
  • ANSI Standards
  • Swiss Regulations
  • Canadian Regulations
  • Australian Regulations
  • Ph, Eur.
  • USP
  • efpia Guidelines
  • EMA Guidelines
  • IMDRF Guidelines

The Modules explained

Monitoring- Modules

Daily Monitoring

PREXEVUS’ data miners run every day to bring you the latest and most up-to-date intelligence.

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Monitoring updates

Our fair service policy includes any addition of a regulation, standard or guideline for free.

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Product assignments

PREXEVUS let’s you assign the standards, regulations and guidelines to products, to portfolios, to sites or the entire company for a structured approach to the monitoring.

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License Management

Each standard can be bought individually and there is no need to buy packages or collections. Never buy a standard twice because a team member doesn’t know about it.

Alerting

Alerting can be specified for each user and for it’s preferences, e.g. whether the user wants to get alerted daily, weekly, monthly, or quarterly.

Fulltext search

PREXEVUS let’s search any document in full text. With this, you don’t need to care which standard is applicable, you simply search for a term specific to your product.

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Monitoring threats

Monitoring is structured in threats. Each monitored document, whether a standard, regulation or guideline, is defined as monitoring threat.