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Medical Device Registration and Compliance

PharmaGXP provides range of services in medical device registration, technical file preparation and acting as UK Responsible Person for Medical Device.

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Medical Device 

Enhanced Documentation and Compliance Support by PharmaGXP

In the fast-paced environment of product development, companies often overlook the critical task of documentation. PharmaGXP team provides essential support by collaborating directly with your design team to draft, review, and update necessary documentation and compliance materials.

 

Our services ensure that your medical device meets all regulatory requirements and is backed by thorough and up-to-date documentation.

Our Documentation and Compliance Services Include:

  • Device History Record (DHR) & Device Master Record (DMR): Essential records that document the production history and overall specifications of your medical device.

  • Design History File (DHF): Comprehensive documentation of the design process to demonstrate compliance with design control requirements.

  • Device Verification and Validation Support: Assistance in proving that your device meets the needs of the end user and complies with industry standards.

  • Human Factor / Usability Engineering: Alignment with IEC 62366 to ensure that devices are designed with user safety and usability in focus.

  • Risk Management: Adherence to ISO 14971 and ISO 24971 for identifying and mitigating risks associated with medical devices.

  • Labelling & Compliance: Ensuring that labelling meets the standards of ISO 15223, MDR GSPR 23, and FDA 21 CFR Part 801.

  • Instructions For Use or User Manual: Clear and concise guidance for end-users, ensuring safe and effective use of the device.

  • Third-party Testing and Validation Support: Includes bench testing, pre-clinical verification, and validation to ensure device efficacy and safety.

  • Biological Risk Evaluation: BEP and BER in compliance with ISO 10993 to assess potential biological risks.

  • Toxicological Assessment: Comprehensive evaluation according to ISO 10993 to analyze any toxicological risks associated with the device.

  • Compliance for Electronic and Software Components: Covering standards such as IEC 60601 for medical electrical equipment, ISO 11607 for packaging for terminally sterilized medical devices, IEC 62304, and IEC 82304 for software as a medical device.

At PharmaGXP, we understand the importance of meticulous documentation and stringent compliance for successful medical device development and market entry.

 

Our team stands ready to ensure your documentation is complete, up-to-date, and regulatory compliant.

 

Reach out today to ensure your medical devices are developed with precision and quality from the ground up.

Senior Businesswoman

Medical Device 
Regulatory Support

PharmaGXP is renowned as an industry leader in facilitating successful regulatory submissions and securing positive outcomes through proactive, daily interactions with major global authorities such as the US FDA, CDSCO (India), TGA (Australia), Taiwan FDA, INVIMA (Colombia), Japan's PMDA, Europe's Notified Bodies, China's NMPA, and other international regulatory bodies.

We offer an extensive range of regulatory services that cover the entire lifecycle of medical device products, from initial design and development through to post-market support. Our services include selecting and negotiating with Notified Bodies, preparing for Pre-IDE, and participating in Advisory Panel Meetings.

 

Our expert teams develop and implement comprehensive global regulatory strategies that accelerate commercialization efforts, enabling quicker market entry and enhancing patient safety and healthcare impact.

Our Comprehensive Services Include:

  • CE/UKCA Technical Documentation for compliance with EUMDR 2017/745 (Medical Devices) and EUIVDR 2017/746 (In-Vitro Diagnostic Devices) and relevant UK regulations.

  • Notified Bodies interaction including selection, negotiation, audit, and coordination until obtaining the CE Mark.

  • FDA Regulatory Submissions such as 510(k) submissions, Pre-Market Approval (PMA), and Investigational Device Exemption (IDE).

  • De Novo Submission and Breakthrough Device Designation (BDD) to facilitate market entry for innovative devices.

  • Management of Regulatory Documentation such as Letter to File (LTF) for changes to existing products, review of marketing and advertising materials, and ensuring compliance in publications.

  • Strategic Regulatory Services including the appointment of a US Agent, establishment registration, and listing with the US FDA.

  • Pre-submission Meetings and ongoing regulatory support.

  • Global Market Approvals including Australia's TGA, ANVISA (Brazil), INVIMA, Taiwan, China's NMPA, Japan's PMDA, and other international registrations.

At PharmaGXP, our goal is to streamline your pathway to market, ensuring that your products meet rigorous regulatory standards while achieving a timely and effective launch.

 

Contact us today to discover how we can enhance your product's journey from conception to market.

Medical Device Clinical Evaluation Service

Medical Device 
Clinical Evaluation
Services

Clinical Evidence and Regulatory Compliance at PharmaGXP

At PharmaGXP, we understand the critical importance of sufficient qualitative and quantitative clinical evidence to demonstrate the safety and performance of medical devices throughout their lifecycle.

 

Our comprehensive clinical services are designed to support this requirement, ensuring that your medical devices meet all necessary regulatory standards for market approval.

Among the diverse clinical services we offer, the following are particularly crucial:

  • Due Diligence: Assessing the need for clinical studies to support device approval.

  • Clinical Evaluation Plan (CEP): Development of a robust plan to guide clinical evaluation activities.

  • Clinical Evaluation Report (CER): Creation and periodic updates to document ongoing clinical evaluations.

  • Clinical Investigation Plan (CIP): Development according to ISO 14155 & Good Clinical Practice (GCP) guidelines.

  • Clinical Investigation Report (CIR): Comprehensive reporting on clinical investigations, aligned with ISO 14155 & GCP.

  • Clinical Investigation Operation Management: Managing operations at clinical investigation sites to ensure compliance and integrity.

  • Post Market Clinical Follow-up (PMCF): Developing protocols and reports to monitor products post-market.

  • Periodic Safety Update Reports (PSURs): Regular updates on device safety post-market.

  • Review of Clinical Data: Thorough analysis to ensure relevance and reliability.

  • Clinical Operations Procedures: Establishing standard operational procedures for clinical trials.

  • Scientific Publication Dashboard: Management of data and findings for scientific sharing.

  • Medical and Scientific Content and Videos: Creation of educational and promotional materials.

  • Key Opinion Leader (KOL) Engagement: Building relationships with industry leaders to enhance product credibility.

  • Post Market Surveillance Strategy and Execution: Implementing strategies for ongoing product evaluation in the market.

  • Complaint Handling and Systems Setup: Establishing robust systems for addressing and documenting customer complaints.

  • Real World Evidence Study Management (RWE): Overseeing studies to collect data from real-world medical settings.

PharmaGXP provides the expertise and comprehensive support necessary to navigate the complex regulatory landscape and achieve successful product approvals.

 

Let us help you demonstrate the safety and efficacy of your medical devices with solid clinical evidence and effective regulatory strategies.

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Medical Device 
Clinical Evaluation
Services

Optimizing Patient Safety and Product Quality with Robust Quality Management Systems at PharmaGXP

The importance of developing, implementing, adhering to, and continually improving a compliant Quality Management System (QMS) is paramount.

 

These critical processes not only enhance company value but are vital in ensuring patient safety and delivering high-quality medical products to those in need.

 

PharmaGXP has a strong track record in providing both premarket and post-market quality systems support. Our most sought-after services include:

  • Quality Systems Setup: Implementation of standards such as ISO 13485, FDA 21 CFR Part 820, and MDSAP to establish a robust framework.

  • Document Control System Setup: Creating systems to manage documentation efficiently and in compliance with regulatory requirements.

  • Software Validation: Ensuring that all software components within the QMS are validated for reliability and compliance.

  • Document Controller Appointment: Designating qualified personnel to oversee document management and control processes.

  • Internal Audit: Conducting audits to assess compliance with internal standards and regulatory requirements.

  • Training Sessions: Providing training on ISO 13485, MDSAP, IEC 62304, and ISO 14971 to ensure staff competence and compliance.

  • Supplier Audits and Monitoring: Evaluating and monitoring suppliers to maintain product quality and compliance.

  • Management of External Vendors: Overseeing mergers, acquisitions, and deals to ensure quality and compliance are maintained throughout transitions.

  • Maintenance of Quality Systems: Continuous upkeep of QMS in accordance with ISO 13485, 21 CFR Part 820, and MDSAP requirements.

  • MHRA/EU/FDA Inspection Preparation: Helping prepare for and navigate FDA inspections.

  • Gap Assessments: Identifying and addressing discrepancies within the QMS.

  • Unique Device Identification (UDI) Implementation: Assisting with UDI compliance to enhance device traceability.

  • CAPA Management: Developing effective corrective and preventive actions to manage and mitigate issues.

  • Annual Renewal of Registration: Managing the annual renewal process for company registration.

  • Annual Renewal of Listing & Agents: Ensuring timely renewal of listings and agent relationships.

  • Complaint Handling and Reporting: Establishing systems to handle complaints effectively and in compliance with regulatory standards.

At PharmaGXP, we are dedicated to supporting your endeavors to maintain the highest standards of quality and compliance.

 

Contact us today to ensure your Quality Management Systems are effective, efficient, and fully compliant.

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