Services Provided By

Happy Scientifics Limited ®

Clinical/Medical Writing

Clinical Evaluation Report (CER) is one of the key changes after the
implementation of MDR where medical device manufacturers struggle to
cope with. We offer complete solution related to Clinical according to EU
MDR

• Clinical Strategy
• Preparation of Clinical Evaluation Plan
• Literature search, appraisal and literature analysis
• Compilation of Clinical Evaluation Report (CER)
• Communication with the notified body and query management
• Post Market Clinical Follow-up report
• Training for CER and PMCF

Regulatory Affairs

We offer a comprehensive range of regulatory services for medical device companies seeking to enter global markets. Our services include: 510(k) notifications, global medical device approval and registration, device registration and listing, new tech files/design dossiers, CE marking/European MDR/IVDR compliance, Health Canada CMDR compliance and licensing, UKMHRA compliance and registration, master file preparation, regulatory gap assessments, post-launch regulatory support, complaint management/adverse event reporting, master file maintenance, tech file/design dossier updates, post-market surveillance, and remediation support for FDA warning letters/483s and CE mark reinstatement. Our team of experts can guide you through the regulatory process and ensure compliance with the latest standards and regulations.

Training

  • Clinical Evaluation Report writing with literature
    search, appraisal and compilation
  • QMS: ISO 13485, ISO 9001, ICH Q10
  • Post Market Clinical Follow-up report
  • EU MDR/IVDR/MEDDEV
  • Good Manufacturing Practice (GMP).
  • Regulatory Requirements for global markets.
  • Design Control.
  • FDA registration process.
  • Biocompatibility of medical devices to manage
    biological risk: ISO 10993
  • Tailored training to suit your organisation

Auditing

❑ QMS Audits: We conduct internal and external audits of our clients’
QMS to ensure compliance with regulatory requirements and identify
areas for improvement.

❑ Supplier audit: We provide guidance on managing suppliers and

ensuring that their quality systems meet the requirements of the
medical device industry.

❑ Internal Audit: …..

  • QMS: ISO 13485, ISO 9001, ICH Q10
  • EU MDR/IVDR/MEDDEV
  • Pharmacovigilance: EU Volume 9b, PV/Adverse Events, Directive
    2001/82/EC
  • MDSAP (Medical Device Single Audit Program)
  • Supplier quality system
  • GxP audits for the pharmaceutical, medical device and related
    industries 21 CFR part 210/211, 820, part 58 (GLP), 21 CFR part
    600
  • Clinical Audit: Clinical Evaluation Report, Post Market Clinical
    Follow-up, Clinical investigation ISO 14155, ICH GCP, ICH E6 /
  • Sterilization of health care products ISO 11135, ISO 11137
  • Biocompatibility of medical devices to manage biological risk: ISO
    10993
  • Medical Device Software: ISO 62304, IEC 82304
  • Medical device Risk Management: ISO 14971,
  • Medical devices utilizing animal tissues and their derivatives: ISO
    22442

MDR/IVDR Transition

We offer a comprehensive range of services to support the compliance of
medical device companies with the EU Medical Device Regulation (MDR)
and EU In Vitro Diagnostic Medical Device Regulation (IVDR). Our services
include:

  •  IVDR/MDR Gap Assessment: We conduct a thorough assessment of
    your current regulatory compliance and identify the gap between your
    current compliance status and the requirements of the IVDR / MDR.
  • Technical File Remediation: We assist in the development and updating
    of your Technical Files to meet the requirements of the IVDR / MDR and
    provide guidance on how to maintain them.
  • Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
    Writing: We help in the preparation and review of CERs and PERs, which is
    a key requirement of MDR and IVDR.
  • Scientific Validity Report writing: we help in the preparation and review
    of SVR.
  • Notified Body Assessment: We provide guidance and support in the
    selection of a Notified Body for IVD and assist in the preparation and
    submission of the application for certification.
  • Training: We offer training on the IVDR / MDR and its requirements,
    including the transition process and the new classification system, to
    ensure that your team is prepared for the changes ahead.

Our team of experts has extensive experience in navigating the regulatory
requirements for IVD / MD and can provide the guidance and support
needed to ensure a successful transition to the IVDR / MDR. We work
closely with our clients to understand their unique needs and develop
customized solutions to support their success.

Templates and Tools

We offer a range of fixed-fee packages that provide the necessary tools and templates to help you comply with the MDR/IVD-Regulation 2017/746. Each package is available for purchase on its own, or you can opt for our training package that includes 2 hours of consulting in addition to the tools and templates. The consulting is focused on the specific topic(s) covered in the package. To purchase one of our IVD-R tool packages, please contact us. We will then send you an invoice for the package, and once
payment is received, the package will be delivered to you via email as soon as
possible.

Our sales packages include all the necessary tools, and here is the entire list of the packages we offer to help you comply with the IVD-Regulation 2017/746. Our templates with guidance include, but not limited to

  1. Technical File
  2. General safety and performance requirements
  3. Performance Evaluation Plan & Report
  4. Analytical Performance Plan & Report
  5. Clinical Performance Plan & Report
  6. Scientific Validity Reports
    a. Literature search and selection protocol
    b. Literature selection tables
    c. Literature search and selection report
    d. Scientific Validity Report

  7. Post-Market Surveillance (PMS)
    a. Post-market Surveillance Plan
    b. Post-market Surveillance Report
    c. Periodic Safety Update Report
    d. Post-market Performance Follow-up Plan
    e. Post-market Performance Follow-up Evaluation Report
    f. Summary of Safety and Performance

  8. Risk Management System
    a. Risk Management Plan
    b. Risk Management Report
    c. Risk Analysis FMEA Tables (incl. examples)
    d. Risk Assessment Record
    e. Roadmap to Risk Assessment

Quality Management

We offer a range of services to support the development and implementation of a Quality Management System (QMS) for medical device companies. Our services
include:

  • QMS Development: We assist our clients in developing a QMS that meets the requirements of ISO 13485, MDR, IVDR and 21 CFR 820, as well as any other relevant international standards.
  • QMS Audits: We conduct internal and external audits of our clients’ QMS to ensure compliance with regulatory requirements and identify areas for
    improvement.
  • Supplier Quality Management: We provide guidance on managing suppliers and ensuring that their quality systems meet the requirements of the medical device industry.
  • CAPA: We help our clients develop and implement a Corrective and Preventive Action (CAPA) system to address non-conformances and prevent recurrence.
  • Risk Management: We assist our clients in identifying, evaluating, and
    controlling the risks associated with their devices throughout the product
    lifecycle.
  • Training: We offer training on various aspects of QMS, including ISO 13485, MDR, IVDR, 21 CFR 820, and other relevant international standards.
We have knowledge and experience to help medical device companies develop and implement a QMS that meets the requirements of the industry and ensures compliance with regulatory requirements. We work closely with our clients to understand their unique needs and develop customized solutions to support their success