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Regulatory Strategy and Support

Navigating regulatory complexities requires a strategic approach. At Medoctra, we offer expert regulatory consulting services to help medical device manufacturers achieve market approvals efficiently and stay compliant across regions.

Consult

How Medoctra Helps

Strategic Consulting
A person is leaning over a table, writing on papers with a pen. There are medical devices, including a blood pressure monitor and a pulse oximeter, on the table. The setting appears to be an informal medical or health-related event, with another person partially visible in the background.
A person is leaning over a table, writing on papers with a pen. There are medical devices, including a blood pressure monitor and a pulse oximeter, on the table. The setting appears to be an informal medical or health-related event, with another person partially visible in the background.

We provide tailored strategies for global market access, aligning your goals with regulatory requirements.

A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
A medical setting with two people, likely healthcare professionals, focusing on a patient who is surrounded by numerous medical devices and monitors. The environment is busy with various tubes and equipment connected to the patient.
A medical setting with two people, likely healthcare professionals, focusing on a patient who is surrounded by numerous medical devices and monitors. The environment is busy with various tubes and equipment connected to the patient.
Regulatory Operations Support

Our team handles document management, publishing, and ongoing maintenance, ensuring efficiency.

Medoctra ensures your Instructions for Use (IFU) and labeling align with applicable regulatory standards.

IFU and Label Management
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person in gray pants on brown and green grass field under white clouds during daytime
person in black long sleeve shirt holding persons hand
person in black long sleeve shirt holding persons hand

Market Approval Services

SaMD Support

We support submissions and approvals in the EU and other global regions, accelerating your market entry.

For Software as a Medical Device (SaMD), we provide specialized regulatory guidance to ensure compliance

Regulatory Consulting Services

Europe
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blue flag on pole near building

  • EU MDD to EU MDR Transition Support

  • EU MDR 2017/745 Compliance

  • List of Applicable Standards

  • Post Market Surveillance Activity

  • PMCF Survey Execution for EU MDR Compliance

  • PMS Strategy and support

  • Clinical Evaluation- Strategy and Support

  • Risk Management

  • GSPR

  • STED

  • EUDAMED Registration

  • Drug Device Combination Products

QMS

  • QMS Strategy and Support

  • Import License

  • Manufacturing/Loan License

  • Test License

CDSCO India Regulatory
woman placing sticky notes on wall
woman placing sticky notes on wall

  • ISO 13485

  • EU MDR 2017/745

  • CDSCO

Trainings

Medoctra's expertise in regulatory consulting streamlined our market approval process. Their strategic approach ensured compliance, making our journey much smoother and efficient. Highly recommend their services!

John Doe

A person wearing a smartwatch writes on a notepad while using a tablet that displays medical images. A stethoscope is positioned close by on a white desk, suggesting a medical setting.
A person wearing a smartwatch writes on a notepad while using a tablet that displays medical images. A stethoscope is positioned close by on a white desk, suggesting a medical setting.

★★★★★

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Contact Us

Reach out for expert regulatory consulting and compliance assistance.

Consulting

Expert guidance for medical device market approvals.

Compliance

Strategy

info@medoctra.com

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