Medical Device development
From conceptualization to realization, we provide support to deliver value while meeting the regulatory comliance and highest standards. Let’s navigate together a sustainable, ethical and safe future!
Our Services
Guiding Success in Medical Device Development
Navigating the complex landscape of Medical Device development demands precision, expertise, and adaptability. From initial concept to market release, medical devices play a critical role in advancing healthcare and ensuring patient safety. OLKON stands as your trusted partner in this journey, providing tailored solutions that align with regulatory standards and propel your projects forward. Our skilled team is dedicated to ensuring that your initiatives thrive, overcoming challenges with strategic insights and technical prowess.
Regulatory Compliance Aligned Flexibility
Medical device development requires solutions that are both versatile and aligned with regulatory compliance. OLKON devises flexible strategies ensuring your projects meet all necessary regulations and in placing your products on the market in both the EU and the USA. By balancing flexibility with adherence to standards, we assure your project’s success without compromise.
Efficient Synchronization
In medical device development, harmonizing regulations and standards is essential. OLKON ensures the efficient synchronization of systems, processes, and protocols. With us, your medical device development is streamlined, boosting functionality and efficiency at each stage and making connection to the regulatory affairs.
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Elevating Excellence in Medical Device Development
Grasping the intricacies in medical device development is vital. OLKON excels in delivering customized solutions. From refining processes to overseeing projects, we have all aspects managed. Collaborate with OLKON to traverse the complexities effortlessly. Our skilled guidance guarantees your projects comply with industry norms, attaining excellence consistently.
At OLKON, we don’t just propose solutions; we integrate into your team. With a rich understanding of functional safety, cybersecurity, and project management, we ensure that your endeavors are not only compliant but also primed for success. Rely on OLKON to uplift your medical device projects to unprecedented levels.
Regulation (EU) 2017/745
Medical Device Regulation
Regulation (EU) 2017/746
In Vitro Diagnostic Medical Device Regulation
EU Medical Device and In Vitro Diagnostic Medical Device Regulation
OLKON consulting services are geared towards helping you navigate these complex regulations efficiently. Whether you are introducing a new product or managing an existing portfolio, our expert team is equipped to guide you through the MDR compliance process, from clinical evaluation and risk management to registration and post-market activities.
Partner with us to ensure your medical devices meet the highest standards of safety and performance, paving the way for a successful European market presence.
Premarket Notification 510(k)
For Class I and II devices
Premarket Approval (PMA)
For Class III devices
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FDA Premarket Submission
Our consulting firm specializes in guiding medical device manufacturers through the FDA’s complex premarket submission landscape. We provide strategic advice, documentation support, and regulatory compliance services to streamline your FDA submission.
Our team of experts is well-versed in the nuances of each submission pathway and can help you choose the most appropriate one for your product. Partner with us to accelerate your product’s journey from concept to market, ensuring compliance with FDA standards and a smoother approval process.
ISO 14971:2019
Medical devices – Application of risk management on medical devices
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Risk Management in line with ISO 14971
Effectively managing risks is crucial in medical device development. ISO 14971 offers a systematic framework for identifying, assessing, and mitigating risks associated with medical devices, ensuring patient safety and regulatory compliance. By implementing ISO 14971, developers can make informed decisions, balancing potential risks and benefits.
This proactive approach to risk management safeguards device functionality and end-user safety while fulfilling regulatory requirements throughout the product lifecycle.
ISO 13485
Medical devices – Quality management systems
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Quality Management in line with ISO 13485
Navigating the medical device development landscape requires adherence to stringent quality and regulatory standards. ISO 13485 establishes a robust Quality Management System (QMS) framework, ensuring compliance with EU Medical Device Regulation (MDR).
By focusing on risk management, design, development, and production, it ensures devices meet regulatory and safety requirements. Aligning with ISO 13485 is essential for MDR compliance, assuring consistent quality and safety in every medical device.
Medical device development
Let us support you in your current challange!
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Project support and coordination
At OLKON, we are committed to facilitating the success of your medical device development projects. From initial planning to execution, we provide comprehensive support and coordination tailored to the specific requirements of medical device development.
Whether tackling unforeseen challenges or contributing as external team members, our expertise ensures your projects progress successfully while adhering to industry standards and regulations.
Process reference
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Project Management
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