Consultant Resources

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.

ISO 13485:2016

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.

MDR 2017/245

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.

ISO 14971

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.

ISO 10993

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.

IEC 62366

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.

IEC 62304

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

Clinical Evaluation

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.

SaMD

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.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com