Medical Devices

We provide comprehensive consulting services for:

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Preparation of technical documentation for medical devices
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Development of regulatory strategies
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Creation of clinical evaluation plans and reports for medical devices
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Implementation of Quality Management Systems in compliance with MDR and ISO 13485
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Auditing of documentation and contract manufacturer audits
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Development pathways for medical devices tailored for R&D or grant applications
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Drafting and reviewing contractual agreements
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Internal training programs for medical device manufacturers

Technical Documentation for Medical Devices

We assist in creating comprehensive technical documentation that complies with the requirements of MDR (Medical Device Regulation) and other relevant standards. This option may includes:

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Product specifications and intended use.
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Risk management documentation (aligned with ISO 14971).
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Biological evaluation reports (per ISO 10993 standards).
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Design verification and validation data.
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Instructions for use (IFU) and labeling requirements.
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Post-market surveillance plans and procedures.

Our approach ensures compliance of documentation with applicable regulations and supports certification processes as well as the introduction of medical devices to the market.

Development of Regulatory Strategies

Our team provides tailored regulatory pathways to ensure timely and compliant product approvals, including:

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Classification of the medical device according to MDR.
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Identification of applicable conformity assessment procedures.
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Coordination with Notified Bodies and competent authorities.
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Support in market entry strategies

Thanks to our experience, we help companies navigate the complex regulatory environment effectively, minimizing the risk of delays and non-compliance.

Clinical Evaluation Plans and Reports for Medical Devices

We assist manufacturers in meeting clinical evidence requirements by:

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Developing clinical evaluation plans in line with MDR and MEDDEV 2.7/1 rev 4.
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Conducting literature reviews and data analysis.
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Preparing clinical evaluation reports (CER) to demonstrate safety and performance.
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Supporting Post-Market Clinical Follow-up (PMCF) plans and evaluations.

Our services help ensure regulatory compliance and support certification processes as well as the introduction of medical devices to the market.

Quality Management Systems in Compliance with MDR and ISO 13485

Our experts support organizations in establishing and maintaining effective Quality Management Systems (QMS) by:

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Conducting gap analyses against ISO 13485 requirements.
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Developing QMS policies, procedures, and manuals.
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Training staff on QMS implementation and compliance.
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Preparing for and supporting certification audits.

With our services, organizations can achieve regulatory compliance and enhance the efficiency of quality processes.

Documentation and Contract Manufacturer Audits

We conduct detailed audits to ensure compliance with regulatory and quality standards, focusing on:

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Review of technical documentation for regulatory alignment.
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Supplier qualification audits to assess contract manufacturers’ capabilities and adherence to quality standards.
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Recommendations for corrective actions and process improvements.

Our audits help identify potential risks and ensure the maintenance of the highest standards of quality and compliance.

Development Pathways for Medical Devices Tailored for R&D or Grant Applications

We help companies navigate the development of medical devices with:

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Strategic planning for product development stages, from concept to commercialization.
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Identifying funding opportunities and aligning development processes with grant requirements.
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Participation in grant submissions, including feasibility studies and projected outcomes.

Our services help companies maximize their chances of securing funding and effectively manage product development processes.

Contractual Agreements

We provide legal and regulatory insight into contractual agreements related to:

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Supplier and contract manufacturer agreements.
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Licensing, distribution, and service contracts.

Our services help ensure that contracts comply with legal requirements and effectively protect our clients’ interests.

Internal Training Programs for Medical Device Manufacturers

Our training solutions are customized to meet the unique needs of medical device companies, including:

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MDR and ISO 13485 requirements.
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Risk management and post-market surveillance practices.
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Clinical evaluation and regulatory pathways.
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Quality system documentation and audit preparation.

Our training programs help teams acquire the knowledge and skills necessary to meet regulatory requirements and maintain the highest quality standards.