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Transforming
Healthcare 

MeinDoc is a consulting firm specializing in Quality, and Regulatory Affairs within the Life Sciences industry. We provide expert guidance to pharmaceutical, and medical device companies, ensuring compliance with global regulatory requirements while optimizing product development and market access strategies.

Expertise

  • Our experience spans around medical device lifecycle, including design, development, verification, validation, regulatory approval, manufacturing and market launch.

  • We provide specialized support to our clients across a diverse array of medical devices, including medical software, In-Vitro Diagnostic devices and Combination Products, covering all risk classifications from low to high.

  • Our proficiency encompasses multiple medical fields, such as cardiovascular care, orthopedics, ophthalmology, oncology, (robotic) surgery, anesthesiology, and more.

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Why Choose Us?

  • Industry Expertise: Our team comprises seasoned professionals with extensive experience in life sciences regulatory and quality landscapes.

  • Tailored Solutions: We customize our consulting services to meet the unique needs of each client, ensuring efficient and effective solutions.

  • Global Reach: Our expertise extends to multiple international regulatory frameworks, allowing clients to navigate complex global markets seamlessly.

  • Commitment to Excellence: We uphold the highest standards of integrity, quality, and regulatory compliance to help our clients achieve their business objectives.

Quality Assurance & Compliance

  • Development and implementation of Quality Management Systems (QMS) in compliance with international standards.

    • ISO 9001/ ISO 13485, EU MDR/ IVDR, 21 CFR 820, MDSAP etc.,

  • Coaching/training in preparation for ISO 13485 certification, including support with management reviews, and supplier qualifications.

  • Implement and maintain Risk Management processes in compliance with ISO 14971.

  • Conducting internal and supplier audits to ensure regulatory compliance.

  • Provide hands-on support during audits and inspections and assist in remediating non-conformities.

  • Structure Technical Documentation per international regulatory requirements.

  • Establish and maintain Post-Market Surveillance processes, including complaint handling, adverse event reporting and FSCAs.

  • Facilitate data-driven continuous QMS improvements.

  • Training programs on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Clinical Practices (GCP).

Our Core Services

Regulatory Affairs

  • Regulatory strategy development for product approvals in the EU, U.S., and other global markets (Australia, Canada, GCC, India etc.,).

  • Prepare Technical Documentation and submissions for CE marking under MDR/ IVDR and/ or FDA 510(k), PMA applications.

  • Liaison with notified bodies and regulatory agencies.

  • Support FDA interactions, including Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications.

  • Support V&V activities, including product specific verification activities, and usability validation per IEC 62366.

  • Post-market surveillance and regulatory compliance maintenance.

  • Post-market clinical follow-up (PMCF) and real-world evidence (RWE) studies.

  • WHO Pre-Qualification for IVDs

  • Deliver Regulatory Affairs training tailored to your needs.

Digital Health

  • Guidance on information security and data protection compliance (e.g., GDPR, HIPAA).

  • Implementation of Information security (ISO 27001), privacy information (ISO 27701) and Artificial Intelligent (ISO 42001) management systems.

  • Training and advisory services on artificial intelligence (AI) and machine learning (ML) applications in life sciences.

  • Risk assessment and mitigation strategies for digital health technologies.

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Trainings

  • Meindoc delivers in-house and public trainings addressing various customer needs.

  • Our training service includes but is not limited to:

    • Quality Management Systems as per ISO 9001/ ISO 13485, EU MDR/ IVDR, 21 CFR 820, MDSAP etc.,

    • Medical Device Single Audit Program (MDSAP)

    • Risk Management according to ISO 14971

    • EU regulations for medical devices (EU MDR/ EU IVDR)

    • Design controls etc.,

In-country representation in EU

Designating an In-Country Representative, also known as an Authorized Representative (AR) in some markets, is required if you’re a manufacturer with no physical location in the market where you are looking to commercialize your medical device or IVD.

  • Meindoc provides service to act as EU Authorized Representative.

  • As Your European Authorized Representative, We Will:

    • Perform a completeness review of your CE technical documentation and confirm that you have carried out an appropriate conformity assessment procedure

    • Verify that the device labeling fulfills the requirements of the MDR/IVDR

    • Keep a copy of the technical documentation at the disposal of the competent authorities to demonstrate the conformity of the device

    • Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices

    • Inform the manufacturer about complaints or reports from healthcare professionals, patients, and users about suspected incidents related to the device.

About us

We want to change the way
the patient understand their Surgical problem

"MeinDoc" translates literally into German as "My Doc," meaning "my doctor." At MeinDoc, our goal is to revolutionize traditional and complicated medical communications, breaking down barriers between doctors and patients. We strive to enhance patients' health literacy significantly by providing state-of-the-art 3D visualizations of their surgical condition and planned procedures.

Meindoc GmbH

Riebeckstraße 28,

04317, Leipzig,

Germany

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