MedTech Journey

Navigate your MedTech company safely through the regulatory maze with BAYOOCARE!

As BAYOOCARE GmbH, we can support you as a MedTech company in various ways in your journey to a medical device.

BAYOOCARE offers specialized services that focus on the regulatory, clinical and quality requirements that you as a MedTech company must meet in order to successfully launch and establish your products on the market.

Regulatory advice and support
Regulatory strategies: BAYOOCARE can support you in developing regulatory strategies to ensure that all regulatory requirements are met in different markets (e.g. EU, US, Asia). This includes the preparation of technical documentation, preparation for audits and submission of marketing authorization applications.
Compliance with MDR/IVDR: Support with compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including the preparation of conformity assessments and the performance of risk analyses.
Clinical evaluation and studies
Clinical evaluation: BAYOOCARE can assist in the preparation and maintenance of clinical evaluations in accordance with the requirements of the MDR/IVDR. This includes the evaluation of clinical data derived from both literature and clinical studies.
Conducting clinical studies: Support in the planning, conduct and monitoring of clinical studies to validate the safety and performance of the medical device. This includes the preparation of study protocols, management of study data and coordination with trial centers.
Clinical evaluation and studies
Post-Market Surveillance (PMS)
Post-market surveillance: BAYOOCARE helps companies set up an effective PMS system that ensures the collection and analysis of post-market safety and performance data. This includes the preparation of Periodic Safety Update Reports (PSUR) and the implementation of vigilance activities.
Risk management: Support for continuous risk management, including the assessment of new risks and the adjustment of risk mitigation measures based on post-market data.
Quality management systems (QMS)
Development and implementation of QMS: BAYOOCARE can help you develop and implement a robust quality management system in accordance with ISO 13485. This includes process optimization, document control and staff training.
Audit preparation and execution: Preparation for internal and external audits, including conducting mock audits and identifying weaknesses in the QMS.
Quality management systems (QMS)
Training and courses
Regulatory training: BAYOOCARE provides training for your employees on regulatory requirements and best practices. This helps to increase internal knowledge and ensure that all team members are up to date with the latest regulations.
Specific training: Training on specific topics such as clinical evaluations, PMS, risk and quality management to ensure the company has the necessary know-how to successfully launch and maintain its products.
Interim management and project management
Interim management: BAYOOCARE can provide experts as interim managers who temporarily take on critical roles in the company, for example in the areas of regulatory affairs, clinical affairs or quality management.
Project management: Support in the management of projects, especially those relating to the development, approval and market launch of medical devices. This helps to manage projects efficiently and within the set deadlines.
Interim management and project management
International market access strategies
Global market access: Support in the development and implementation of market access strategies for international markets. This includes adapting to country-specific requirements and coordinating approval processes in different regions.
Product monitoring and improvement
Feedback loops: BAYOOCARE can help set up effective feedback loops to systematically capture customer and user feedback and translate it into product improvements.
Lifecycle management: Support in the lifecycle management of the product to ensure that the product continuously meets market requirements and adapts to regulatory changes.
Product monitoring and improvement

BAYOOCARE GmbH can support you as a MedTech company in every phase of your journey – from development and approval to market launch and beyond. Through comprehensive services in the areas of regulatory affairs, clinical evaluation, quality management and post-market surveillance, BAYOOCARE helps companies to master the complex requirements of the MedTech industry and bring their products safely and successfully to market.

Are you looking for a partner to support you in the area of medical device compliance? Or do you need advice from our experts? Simply contact us without obligation and talk to us about your concerns.

Your contact to us

Navigate your MedTech company safely through the regulatory maze with BAYOOCARE!

Regulatory advice and support

Clinical evaluation and studies

Clinical evaluation and studies

Post-Market Surveillance (PMS)

Quality management systems (QMS)

Quality management systems (QMS)

Training and courses

Interim management and project management

Interim management and project management

International market access strategies

Product monitoring and improvement

Product monitoring and improvement