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Medical devices

Our pharmaceutical division supports pharmaceutical laboratories and biotechnology companies in the development of new products, production and batch release as well as compliance with regulatory, quality and clinical requirements.

  • R&D

    Research

    Design/calculation study
    Clinical assessment
    Clinical validation
    Packaging validation
    Validation of mechanical performance of products
    Compliance control of scientific data

    Development

    Assistance in the creation of design dossiers
    Clinical evaluations (with state of the art)
    Formalisation of the technical file (applicable regulatory and normative requirements, forecast risk analysis)
    Formalisation of design input data
    Review of design dossiers
    Support in the drafting of materials (user manuals, sales materials, etc.)

    Design

    Mechanics: design and industrialisation of parts (e.g. orthopaedic implants, instruments, “hardware” elements of electro-medical equipment, etc.), production using CAD software, then production by machining, plastics, foundry, forging, 3D printing, etc.
    Electronics: design and industrialisation of electronic components (electromechanical system, electronic cards, etc.)
    IT: design (code) of one or part of a computer program considered to be a medical device or part of a medical device.

  • Production

    Process engineering

    Risk analysis (AMDEC, etc.)
    Industrial maintenance
    Process optimisation
    Change management
    Production support

    New works and maintenance

    Technical business management (from specifications to the commissioning of equipment/utilities / buildings)
    Drafting specifications
    Supplier consultations
    Technical assessment of responses
    Management of subcontractors/Planning
    Factory Acceptance Test/Site Acceptance Test
    New works & revamping: Infrastructures & buildings Utilities and equipment

    Supply Chain

    Analysis and monitoring of transport conditions (logistical complaints, temperature excursions, etc.)
    Coordination of recalls/ batch withdrawals
    Change control and CAPA monitoring at the level of the distribution chain
    Establishment/modification of distribution channels
    Support for depositaries
    Qualification of the suppliers
    Monitor the implementation and compliance with BPDG

    HSE

    QHSE technical supervision (extension projects, maintenance, technical shutdowns)
    Implementation of safety receptions, prevention plan and fire permits
    Verification of the qualification of the stakeholders
    Verification of equipment compliance
    Occupational Risk Assessment
    Assistance in setting up and monitoring means of protection (EPI/EPC)
    Control of the good practice of the applicable standards and instructions (auditing)
    Specific tasks: ISO14001: 2015, OHAS18001: 2007, ISO45001: 2018, MASE, ICPE files, chemical risk assessment, ATEX study

  • Quality Assurance

    QA system

    Implementation and Optimisation of the SMQ
    Identification and mapping of processes
    Deployment of normative requirements and GxP benchmarks, 21 CFR part 820, ISO13485: 2016, ISO9001: 2015
    Preparations for inspections (ANSM, FDA) and for internal audits
    Implementation and Optimisation of the SMQ depending on the needs of the company
    Document management (Writing of SOP, WI, quality manual …) and training
    Risk management approach

    Operational QA

    CAPA Management
    Deviations, anomalies, non-conformities and change control
    Customer Complaints management
    Product quality
    Management of production documentation, validation procedures, instructions. Document management tool (Access, Excel, VBA, specialised GED)

    Contrôle qualité

    Quality Control
    Analysis of the end product
    Analysis of anomalies, OOS and OOT
    Data integrity

  • Qualification, Validation and Computer System Validation

    Qualification / Validation

    Qualification/Initial validation, retrospective and periodical
    Equipment (production, conditioning, control), Premises, Utilities
    FAT/SAT
    Process validation (machining, moulding, coating)
    Special processes (surface treatment, cleaning, packaging, sterilisation 11135/11137, biocompatibility 10993)

    Validation of Computerised/ Automised systems

    ERP, LIMS, MES, 21 CFR part11
    Traceability matrix, risk analyses, Validation Master Plan, test plan
    Execution of tests (QI/QO/QP), Validation report and production
    Data Integrity

  • Regulatory Affairs

    Consultation and update of cases

    Determination of the class of medical devices
    Total creation and upgrading of technical files
    Writing of clinical evaluations according to the new regulations (2017/745 & 2017/746) and the MEDDEV 2.7/1 rev 4 guide
    EC marking dossier, 510k, export (China, Japan, Mexico)
    Risk analysis
    Respecting ISO 13485 : 2016

    Registration and Submission

    Operational and strategic support
    Drafting, submission and consideration of comments
    Recording Medical devices

    Vigilance

    Normative and regulatory regulation
    Gap analysis
    Medical devices vigilance/ Responsive vigilance
    Post-Market surveillance
    Biocompatibility
    Physico-chemical validation (see Validation tests)
    Studies and clinical follow-up

  • Clinical Affairs

    Implementation of clinical studies

    Drafting of key documents
    Submission of documents to the relevant authorities
    Managing amendments
    Development of clinical trial protocols
    Design of clinical studies, pre/post market

    Selection and monitoring of CRO

    Benchmarking of a pre-defined panel
    Logistics of the investigator centres (selection, organisation of training and information, study monitoring)

    Post Marketing Surveillance

    Medical devices vigilance : management of adverse events
    Analysis of clinical data
    Clinical studies of post-marking surveillance (PMCF Studies)

500+
dossiers filed to the relevant authorities
50+
clients with whom we work regularly
100+
Consultants specialised in life sciences careers

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