Welcome to Kounter-Intuitive Technologies
Provides Worldwide Regulatory Services for Class I to Class III medical devices
We are Expert in Medical Device Regulatory Affairs. With [08] years of experience in the industry,
Welcome to Kounter-Intuitive Technologies
We are Expert in Medical Device Regulatory Affairs. With [08] years of experience in the industry,
About Kounter intuitive technologies
We are Expert in Medical Device Regulatory Affairs. With [08] years of experience in the industry, we specialize in helping medical device companies ensure compliance with global regulatory requirements. Our commitment to excellence and unwavering dedication to quality set us apart as the go-to partner for regulatory success.
Our Services
Prepare a comprehensive Technical File for various regulatory agencies (CE, FDA, SFDA, IVDR, and UKCA) to ensure compliance for medical devices, regardless of their risk level. This file includes detailed documentation on device design, manufacturing, testing, clinical data, and risk assessment, enabling market access and ensuring safety across different regions.
Creating Clinical Evaluation Reports (CERs) involves assessing the safety and performance of medical devices. These reports summarize clinical data and studies to demonstrate device efficacy and safety. They are crucial for regulatory compliance and ensuring that devices meet the necessary standards for approval and continued market access.
Biological Evaluation Reports (BERs) are documents that assess the biological safety of medical devices. These reports analyze potential risks associated with device materials and interactions with the human body. They are essential for regulatory compliance, ensuring that devices are biocompatible and safe for use in healthcare settings.
Implementing Quality Management involves establishing processes and systems to ensure products or services meet defined quality standards. It encompasses planning, control, and continuous improvement to enhance efficiency, consistency, and customer satisfaction. Quality Management is vital for organizations to deliver high-quality products and services while minimizing errors and defects.
Kounter intuitive technologies boasts 100+ delighted clients.
KIT has successfully completed over 100 projects.
Why Us
Choose us because our [08] years of experience make us experts in medical device regulatory affairs. We offer global compliance solutions, personalized services, and an unwavering commitment to excellence. When you partner with us, you’re choosing regulatory success.
Our Clients
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Appointment
STANPHARMA Ltd., Netherlands
Contact
Thank you for your interest in Kounter Intuitive Technologies! We are excited to hear from you and ready to assist with any inquiries you may have. Feel free to reach out to us through the following contact methods:
info@kounterintuitivetechnologies.com
+923348555088
Office No.103 1st Floor Block-5 Lane-2 Times Square Commercial Bahria Town Phase-7 Rawalpindi