Consulting focuses

Consulting focuses

We offer you comprehensive advice in the areas of pharmaceutical industry, medical technology and life science engineering. Our experts support you in the implementation of projects and the implementation of processes and systems.

Our experienced team is available to assist you with any questions you may have regarding the services listed below. Here we present our key topics and services to you. These pages are always kept up to date. If you still can't find what you're looking for, just contact us - we'll be happy to help you.

Quality management

Medical technology:

Qualification / Validation

    Development of qualification plansExecution of equipment qualificationSpecification development for validationExecution of process validationCreation of training programs for employees in the area of qualification and validationContinuous updating and review of qualification and validation proceduresInternal audits to ensure conformity with ISO 13485 and to identify opportunities for improvement

CAPA & NC

    Identification and elimination of deviations and defectsDevelopment of error prevention measuresDetection and analysis of non-conformitiesDevelopment of detailed plans for corrective and preventive measures.Systematic capture and analysis of non-conformitiesContinuous monitoring, documentation and reporting on CAPA and NC measures

RA in medical technology

    Advice and support in regulatory matters in the pharmaceutical industryRegulation (EU) 2017/745 for medical devicesRegulation (EU) 2017/746 for in vitro diagnostic medical devicesRequirements of the FDA (USA)Requirements of international regulatory authorities for medical devicesCFDA/NMPA (China) - Requirements

Technical Documentation

    Technical documentation in accordance with Regulation (EU) 2017/745Special requirements for medical devicesSoftware development in accordance with IEC 62304/IEC 82304

Clinical evaluation

    Clinical evaluation of medical devicesClinical studiesPost-market surveillance/post-market clinical follow-up

Risk management

    ISO 14971 for medical devicesRisk management according to IEC 80001-1Interface to the biological assessment plan

Audits and Inspections

    Remote audits Internal audits Supplier audits Audits by authorities or notified bodies

Usability

    Requirements for the usability of medical devices according to IEC 62366Usability-Risk Management-Clinical Assessment-Post-Market Surveillance

Biocompatibility

    Biological assessment of medical devicesBiological assessment strategyBiological assessment plan and report

Post Market Surveillance

    Ensure that safety monitoring processes meet regulatory requirements.Develop and implement action plans to improve product safety monitoring.Train employees on current developments and best practices in product safety monitoring.Communicate with authorities documentation and reporting

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