Medical Devices
We provide comprehensive consulting services for:
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:
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:
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:
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:
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:
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:
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:
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:
Our training programs help teams acquire the knowledge and skills necessary to meet regulatory requirements and maintain the highest quality standards.