CE-marking/ Regulatory Support

  • Product Classification
    A product needs to be classified, WQRE can support to establish the proper conformity assessment procedure.
  • Conformity assessment
    Depending on the classification of the product the proper procedure must be chosen and followed in order to affix the CE-marking.
  • MDR support
    WQRE can support in MDR compliancy, and clarification.

Authorized European Representative

  • An authorized representative with a physical office in the European Union needs to be appointed to handle defined, per MDR, regulatory matters. WQRE can act as your European Authorized Representative.
  • Personal contact and attention. You get a dedicated personal case manager so that you always deal with the same person.
  • WQRE knows all the ins and outs of regulatory affairs in Europe. We have good contacts with all authorities
  • Our specialization is quality and regulatory services to medical device
  • All activities regarding complaint handling and the evaluation and notification of adverse events.

Quality Assurance / Implementation of Quality Management Systems

  • Design of your Quality Management System (ISO 9001, ISO 13485, QSR)
  • Support and/or realization of all necessary documentation for an efficient QMS
  • Gap analysis, training and support in the certification process, and training on other relevant QMS related aspects.
  • Support with the suppliers assessments and controls, including supplier auditing
  • Management of sub processes such as Market Vigilance, Suppliers management, internal auditing, etc.

Regulatory pathway analysis

  • Identification of the applicable laws and standards
  • Definition of the most appropriate conformity assessment procedure
  • Realization of the Quality Plan which includes all necessary validations prior entering on the market.
  • Realization of the complete Quality Management for your project / product
  • Communication with the Regulation Authorities

Third party (internal/external) audits

  • Complete compliance audit according to ISO 9001 / ISO 13485 standards and QSR
  • Supplier audits in the view of Quality System management
  • Manufacturing audits to evaluate the performance of a given supply chain
  • Process audit to evaluate the conformance of a manufacturing process to specifications

Design of Technical files/dossier

  • Realization and/or support in the documentation of your technical file
  • Identification and/or completion of the necessary validation activities
  • Independent review of your technical file prior to its submission (CE and US-PMA/510(k))
  • Implementation of a manufacturing strategy which complies to the applicable regulatory requirements
  • Review of the labelling and Instructions for Use.
  • Develop and implement risk management processes

Statistical validation support

  • IQ/OQ and PQ
  • Statistical data analysis (to support product releases)
  • Statistical training
  • Black belt (6 sigma methodology)

Risk Management

  • Risk analysis at the company, at the application, design or process levels
  • Realization and documentation of risk analysis
  • Coaching for implementing mitigation