Pharma Journey – BAYOOCARE

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

BAYOOCARE helps you to cope with the complex requirements of the highly regulated medical device sector and to effectively master the differences in approval requirements.
As BAYOOCARE GmbH, we can support you as a pharmaceutical company at various levels in the development, approval and marketing of a medical device. Here are some key areas of support:

Regulatory advice and approval
Regulatory strategy: BAYOOCARE helps you to develop a customized approval strategy for the highly regulated medical device environment that meets the specific requirements of the target markets. This includes a detailed analysis of the regulatory requirements (e.g. MDR in the EU or FDA in the US). Although there are similarities to the regulations in the pharmaceutical sector, there are significant differences in the requirements and approval procedures.
Documentation and submission: We support you in creating and maintaining technical documentation and in communicating with notified bodies and authorities.
Approval preparation: BAYOOCARE can assist you in carrying out the necessary steps for approval, including the preparation of risk management and clinical evaluations. Particular attention is paid to the specific regulatory requirements for medical devices, which often differ from those in the pharmaceutical sector.
Quality management systems (QMS)
ISO 13485-compliant QMS: We support you in implementing or optimizing your quality management system that meets the requirements of ISO 13485. A stable QMS is crucial for compliance with regulatory requirements in the field of medical devices, which have a different focus than the systems used in the pharmaceutical sector.
Internal audits and supplier audits: We conduct audits to ensure that your company and partners are meeting quality standards in the highly regulated medical device field.
Education and training: BAYOOCARE offers training on regulatory requirements, quality management and relevant processes to ensure that your pharmaceutical company’s employees are well prepared.
Clinical evaluations and trial
Planning and conducting clinical trials: We support you in the design and conduct of clinical trials to demonstrate the safety and performance of the medical device. Instead of proving the pharmacological effect as in clinical studies, the focus is on the technical performance, clinical efficacy and safety of the medical device.
Clinical evaluation: We support you in the preparation of clinical evaluations that are necessary to fulfill regulatory requirements.
Post-Market Clinical Follow-up (PMCF): Development and implementation of PMCF strategies to monitor the ongoing safety and efficacy of your product after market launch.
Risk management and Conformity assessment procedure
Risk management: BAYOOCARE can support you as a pharmaceutical company in implementing and maintaining a systematic risk management process in accordance with ISO 14971. This includes the identification of potential risks, their evaluation and the implementation of measures to minimize risks. This is particularly important in the highly regulated environment of medical devices, which places specific requirements on risk assessment and minimization
Conformity assessment: We support you in the preparation and implementation of the conformity assessment required for CE marking of the product. The conformity requirements often differ fundamentally from those in the pharmaceutical sector.
Product life cycle management
Post-Market Surveillance (PMS): Implementation of PMS processes to continuously monitor the performance of your product after market launch and make adjustments if necessary.
Process Optimization: We as BAYOOCARE can support you in optimizing processes along the product life cycle to increase efficiency and cost effectiveness.
Change management: Support in the implementation of changes to the product or processes to ensure that all changes comply with regulatory requirements and are documented.
Market access and strategic consulting
Market access strategy: We support you in developing a market access strategy that takes into account the specific requirements and competitive conditions in the target markets.
Strategic consulting: We advise you on current trends and developments in the medical device sector so that you, as a pharmaceutical company, can make informed decisions that meet the specific challenges and characteristics of this highly regulated environment.
Project management and operational support
Project coordination: We at BAYOOCARE can take over the project management to ensure that all steps in the development process run smoothly and that the project goals are achieved.
Resource planning and allocation: We can help you plan and allocate resources for the different phases of the project.
Documentation support: We at BAYOOCARE can help you create and maintain the necessary documentation required for product development and approval.

Overall, BAYOOCARE offers you comprehensive services that make it easier for pharmaceutical companies to enter the medical device sector. With our expertise in quality management, regulatory compliance and clinical development, BAYOOCARE can help you meet the complex requirements of the medical device market and successfully bring your products 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 pharmaceutical company safely through the regulatory maze with BAYOOCARE!

Regulatory advice and approval

Quality management systems (QMS)

Clinical evaluations and trial

Risk management and Conformity assessment procedure

Product life cycle management

Market access and strategic consulting

Project management and operational support