for project excellence
Medicologic stands ready to support Medical device and Pharma-industry companies like yours. With a dedicated team of over 40 consultants, we’re here to assist whenever you might need it.
Standards, certifications and experience
Expand your project and team with our consultants
Navigating the complexities of the Regulatory landscape can be challenging, and that’s where our expertise comes in.
From operational insights to supply chain optimization, R&D strategies, and more, our consultants has a high level of knowledge to assist you in overcoming hurdles.
Medical devices - Quality management systems
ISO 13485 outlines criteria for establishing a comprehensive quality management system for medical devices. It guides organizations in meeting regulatory requirements, ensuring product safety, and maintaining efficient processes across the device’s life cycle, from design and production to post-market activities.
Regulation (EU) 2017/745 on medical devices
MDR 2017/245 is an EU regulation setting forth stringent standards for the safety, performance, and quality of medical devices. It defines the regulatory framework, ensuring conformity and traceability throughout the supply chain, emphasizing patient safety and public health.
FDA CFR 21 Part 820
Quality System Regulation (Current Good Manufacturing Practice - CGMP)
FDA CFR 21 Part 820 establishes the quality system requirements for medical device manufacturers in the U.S. This regulation enforces compliance with Current Good Manufacturing Practices (CGMP), covering design controls, production processes, and post-market surveillance to assure product quality and safety.
Medical devices Risk management
ISO 14971 provides a systematic approach to managing risks associated with medical devices. It guides manufacturers in identifying, evaluating, and mitigating potential hazards, ensuring a proactive risk management process throughout the device life cycle, fostering patient safety.
Biological evaluation of medical devices
ISO 10993 establishes a framework for assessing the biological safety of medical devices. It outlines testing methods to evaluate potential adverse effects on living tissues, addressing concerns related to cytotoxicity, genotoxicity, and other biological risks to ensure device biocompatibility.
Medical devices Usability
IEC 62366 provides guidelines for integrating usability engineering into the design of medical devices. It emphasizes user-centered design, aiming to enhance product usability, user satisfaction, and overall safety, with a focus on minimizing use-related hazards.
Medical device software
IEC 62304 outlines software life cycle processes specific to medical devices. It defines requirements for software development, validation, and maintenance, ensuring the safety and effectiveness of medical device software throughout its life cycle, from conception to retirement.
MEDDEV 2.7.1 provides guidance on conducting clinical evaluations of medical devices in accordance with EU directives. It assists manufacturers and notified bodies in planning, conducting, and documenting clinical evaluations, ensuring compliance with regulatory requirements and patient safety.
Software as a Medical Device (SaMD)
SaMD establishes key definitions and guidelines for software intended as a standalone medical device. It clarifies regulatory considerations, ensuring that software developers adhere to appropriate standards, risk management practices, and safety requirements when developing medical software.
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.