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