Medical Device Documentation & Compliance Services
In the fast-paced environment of product development, companies often overlook the critical task of documentation. At PharmaGXP, we provide 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.
- Device History Record (DHR) & Device Master Record (DMR)
- Design History File (DHF)
- Device Verification and Validation Support
- Human Factor / Usability Engineering
- Risk Management
- Labelling & Compliance
- Compliance for Electronic and Software Components
- Toxicological Assessment
- Biological Risk Evaluation
- Third-party Testing and Validation Support
- Instructions for Use or User Manual
Comprehensive Regulatory Services
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.
- 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.
- Global Market Approvals including Australia's TGA, ANVISA (Brazil), INVIMA (Colombia), Taiwan FDA, China's NMPA, Japan's PMDA, and other international registrations.
- Strategic Regulatory Services including the appointment of a US Agent, establishment registration, and listing with the US FDA.
- 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.
- De Novo Submission and Breakthrough Device Designation (BDD) to facilitate market entry for innovative devices.
- FDA Regulatory Submissions such as 510(k) submissions, Pre-Market Approval (PMA), and Investigational Device Exemption (IDE).
Comprehensive Regulatory Services
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.
- 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
Medical Device Clinical Evaluation & Quality Management Services
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 Audits: 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.
- Inspection Preparation (MHRA/EU/FDA): Helping prepare for and navigate FDA and other regulatory 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.
Why Choose PharmaGXP?
Expert Guidance
Our team has extensive knowledge of regulatory requirements, ensuring that you remain compliant throughout the process.
Dedicated Support
We offer ongoing support, from the initial consultation to maintaining the license.
Seamless Process
We manage the entire application process, minimizing stress and helping you secure your license quickly.