Services

Regulatory Writing

  • Clinical & regulatory documents

    • Clinical evaluation reports (CERs) for all types of medical devices
    • Clinical evaluation plans (CEPs)
    • State-of-the-art (SOTA) reports
    • Summaries of safety and clinical performance (SSCPs)
    • Post-market clinical follow-up (PMCF) plans and reports
    • Post-market surveillance (PMS) plans and reports
    • Periodic safety update reports (PSURs)
    • Clinical investigation plans (CIPs) and reports (CIRs)
    • Investigator’s brochures (IBs)
    • Clinical risk management support

  • Literature search

    • Systematic literature search with multiple search engines and bibliographic databases
    • Literature search protocols (LSPs) and reports (LSRs)
    • Full-text screening and article selection
    • Appraisal of clinical evidence
    • Data pooling and literature review

  • Information materials

    • Instructions for use (IFUs)
    • Surgical technique guides
    • Technical manuals
    • Product brochures
    • Patient information leaflets

  • Areas of clinical and regulatory expertise

    • Orthopaedics: hips, knees, shoulders, small joints, biomaterials, instruments
    • Spine: interbody fusion cages, posterior fixation devices, pedicle screws, resorbable implants, navigated surgery
    • Biotech: advanced wound care, blood purification, hyaluronic acid fillers
    • Trauma: plates and screws, intramedullary nails, external fixators, biomaterials, instruments, patient-specific implants, surgical planning software
    • Sports medicine: anterior cruciate ligament reconstruction, coracoclavicular ligament reconstruction, biomaterials, instruments, intraarticular injections
    • Lung function diagnostics: spirometers, lung function analysers, filters, spirometry software
    • Craniomaxillofacial surgery: plates and screws, biomaterials, patient-specific implants, surgical planning software
    • Dental: dental implants, abutments, biomaterials, instruments, dental equipment
    • General surgery: sutures, general surgical instruments, electrosurgical instruments
    • …and more

Medical Writing & Communications

  • Medical writing

    • Journal articles / manuscripts
    • Abstracts
    • Conference posters
    • Publication planning
    • Article submission and resubmission
    • Assistance with peer-review processes
    • Manuscript translations from German or French to English
    • Literature review
    • Grant proposals
    • Clinical study protocols and reports
    • Basic statistical support
    • Editorial services: proofreading and editing

  • Medical communications

    • Scientific flyers and brochures
    • White papers
    • Scientific slide decks / presentations
    • Evidence-based claim sheets
    • Advisory board meeting minutes
    • Sales-support information
    • Training materials for health care professionals
    • Medical education materials
    • Scientific press releases
    • Lay summaries

Medical writing service levels

  • editorial services I

    Light editorial services

    • Proofreading
    • Light editing

    Contact us

  • Editorial services II

    Substantial editing

    • Proofreading
    • Scientific / medical content review
    • Substantial scientific editing and rewriting
    • Reference management
    • Professional copy editing
    • Preparation of submission package

    Contact us

  • Medical writing I

    Standard medical writing

    • Medical writing from scratch
    • Proofreading
    • Scientific editing
    • Reference management
    • Professional copy editing
    • Preparation of submission package

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  • Medical writing II

    Medical writing & publication support

    • Publication planning
    • Target journal selection
    • Communication with journal (pre-submission enquiries etc.)
    • Medical writing from scratch
    • Proofreading
    • Scientific editing
    • Reference management
    • Professional copy editing
    • Preparation of submission package
    • Article submission

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  • Resubmission

    Support during peer-review

    • Point-by-point answers to peer-review comments
    • Revision of manuscript
    • Reformatting
    • Preparation of submission package

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  • Some examples of our work

    1. Rochcongar | 2018 | Creep and wear of vitamin E-infused HXLPE cups | JBJS Am | DOI link
    2. Hochreiter | 2020 | Bone remodelling after short-stem total hip arthroplasty | Int Orthop | DOI link
    3. Hess | 2021 | Biomechanical study on olecranon osteotomy | JSES Rev Rep Tech | DOI link | PDF
    4. Reuther | 2022 | Conversion reverse total shoulder arthroplasty | J Clin Med | DOI link | PDF
    5. Anderl | 2022 | Bone preservation in total hip arthroplasty | J Arthroplasty | DOI link | PDF
    6. Barton | 2019 | Vein dilation for intravenous cannulation | J Vasc Access | DOI link
    7. Loukidis | 2024 | Case report on azacytidine in myelodysplastic syndrome | Leuk Res Rep | DOI link | PDF

    We will gladly provide you more examples on request.

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Clinical & RegulatorY Support

  • Clinical support

    • Clinical strategy and regulatory pathway
    • Clinical process development
    • Clinical data overview and gap analysis
    • Clinical support during early-stage product development
    • Evidence-based decision-making
    • Scientific opinion
    • Medical writing guidance development
    • Medical writing coaching of researchers

  • Regulatory support

    • Technical documentation review
    • Regulatory support for complete risk management file (RMF)
    • Technical support for verification and validation activities
    • Biocompatibility support
    • Regulatory document templates and standard operating procedures
    • Tailored training and workshops
    • Deficiency handling

  • Free clinical and regulatory expertise

    We offer a free, no-obligation initial meeting (15 min) to discuss clinical and regulatory topics relating to medical devices.

    Contact us

Are you interested in our services? Contact us.