Medical Devices

Combination Medical Device QMS Setup and Management Services

TDP specializes in Combination Medical Device Quality Management System (QMS) Setup and Management, ensuring effective compliance with complex regulations. 

Expert QMS Setup: Our experienced team crafts tailored QMS for combination medical devices aligned with ISO 13485 and ISO 14971 standards. 

Regulatory Compliance: We guide you through regulatory requirements, ensuring your QMS meets global standards set by authorities like the FDA and EMA. 

Risk Management: We develop and implement risk management processes to maximize patient safety and minimize potential hazards. 

Document Control and Training: Our robust document control systems manage all documentation, and comprehensive training programs ensure personnel compliance with QMS requirements. 

Continuous Improvement: We implement performance monitoring systems to track QMS effectiveness, driving ongoing improvement through corrective and preventive actions.

Why Choose Us: 

  • Expertise: Our team comprises regulatory experts and industry veterans with extensive experience in combination medical device QMS management. 

  • Customized Solutions: We offer tailored solutions to meet the unique needs of your combination medical device products and operations. 

  • Regulatory Compliance: TDP stays updated with the latest regulations, ensuring ongoing compliance with all standards. 

Partner with TDP for excellence in quality and compliance. Contact us today to learn more. 

Book a 30 min consultation to discuss your needs.

ISO 13485 Medical Devices Auditing

TDP offers trusted ISO 13485 Medical Devices Auditing services, ensuring compliance with international quality management standards. 

Comprehensive Audits: Our experienced auditors conduct thorough evaluations of your processes, procedures, and documentation, identifying areas for improvement and ensuring regulatory compliance. 

Internal & Supplier Audits: We assess your organization's quality management system and supplier systems, ensuring they meet ISO 13485 standards for high-quality and reliable supply chains. 

Gap Analysis: Our gap analysis assessments compare your current system with ISO 13485 requirements, providing a roadmap for achieving compliance. We will Guide you through Solution Devlopment and implementation. 

Regulatory Compliance: We help navigate the regulatory landscape and implement best practices to meet ISO 13485 and other relevant regulations. 

Why Choose Us: 

  • Expertise: Our auditors have extensive experience in medical device quality management and regulatory compliance. 

  • Tailored Solutions: We offer customized auditing services to meet your organization's specific needs. 

  • Commitment to Compliance: TDP ensures your compliance with ISO 13485 and other regulations, providing confidence in your quality management processes. 

Partner with TDP for excellence in quality management and regulatory compliance. Contact us today to learn more.

Book a 30 min consultation to discuss your needs.

ISO 13485 and ISO 14971 Supply Chain Setup and Management

TDP is your partner for ISO 13485 and ISO 14971 Supply Chain Setup and Management. We ensure your supply chain meets top-quality, safety, and regulatory standards. 

QMS Setup (ISO 13485): We assist in establishing robust QMS aligned with ISO 13485 standards, ensuring compliance and continuous improvement. 

Risk Management (ISO 14971): Our experts integrate risk management processes seamlessly into your QMS, promoting product safety and efficacy. 

Supplier Qualification: We conduct thorough assessments to ensure supplier quality and regulatory compliance, maintaining supply chain integrity. 

Regulatory Compliance: We guide you through ISO 13485 and ISO 14971 requirements, ensuring compliance with global regulatory authorities. 

Continuous Improvement: Our support includes driving continuous improvement through audits, performance monitoring, and CAPA implementation. 

Why Us: 

  • Expertise: Our team brings extensive experience in quality and risk management. 

  • Tailored Solutions: We offer customized approaches to meet your specific needs. 

  • Regulatory Commitment: TDP ensures compliance with ISO standards, providing confidence in your medical devices' safety and effectiveness. 

 Partner with TDP for excellence in quality management and regulatory compliance. Contact us today to learn more. 

Book a 30 min consultation to discuss your needs.

ISO 13485 Inspection Readiness

TDP is your trusted partner for ISO 13485 Inspection Readiness, ensuring compliance with international standards for medical device manufacturers and suppliers. 

Specialization: We specialize in supporting organizations manufacturing combination devices, sterile, and aseptic products, ensuring compliance and safety standards are met. 

Preparation and Training: Our tailored programs equip your team with the knowledge to navigate ISO 13485 inspections effectively, covering key topics such as quality management principles and documentation requirements. 

Gap Analysis and Mock Inspections: We conduct thorough reviews and mock inspections focused on combination devices, sterile, and aseptic products, providing insights and recommendations for improvement. 

Regulatory Compliance Assistance: Our specialized assistance ensures your organization stays updated with ISO 13485 standards and regulatory expectations for these product types. 

Continuous Improvement: We collaborate to implement corrective actions based on inspection findings, addressing unique challenges and requirements of these products. 

Why Us: 

  • Expertise: Our team comprises regulatory experts and industry veterans with specialized experience. 

  • Tailored Solutions: We offer customized approaches to meet your organization's unique needs. 

  • Commitment to Excellence: TDP is dedicated to ensuring compliance and safety in specialized areas. 

Partner with TDP for excellence in quality management and regulatory compliance. Contact us today to learn more about how our services can support your organization's success. 

Book a 30 min consultation to discuss your needs.

Technical File Creation

TDP is your premier partner for Technical File Creation, ensuring the safety, efficacy, and compliance of your medical device with regulatory requirements. 

Comprehensive Documentation: We gather and compile all necessary documentation and data required for the Technical File, ensuring accuracy, completeness, and organization according to regulatory standards. 

Regulatory Compliance: Our team ensures your Technical File meets standards like ISO 13485, ISO 14971, and EU MDR, minimizing delays during regulatory review and approval. 

Risk Management Integration: We integrate risk management principles throughout the process, identifying and mitigating potential risks to enhance product safety. 

Clinical Evaluation Support: For devices needing clinical evaluation, we assist in compiling and documenting clinical data and evidence in compliance with regulations. 

Ongoing Support: We provide maintenance and updates to keep your Technical File accurate and compliant with evolving regulations and product specifications. 

Why Us: 

  • Expertise: Our team comprises regulatory experts and medical device specialists with extensive experience. 

  • Regulatory Compliance: We ensure your Technical File meets all regulatory requirements, minimizing delays. 

  • Customized Solutions: Tailored approaches meet your device's specific needs, ensuring a thorough and compliant Technical File. 

Partner with TDP for excellence in regulatory compliance and documentation. Contact us today to support your device's development and regulatory approval processes. 

Book a 30 min consultation to discuss your needs.

Ongoing Quality Management (all classes) & Combination Products

TDP is your trusted partner for Ongoing Quality Support for medical devices and combination products, ensuring compliance, safety, and effectiveness throughout their lifecycle. 

Comprehensive Solutions: From Class I to Class III devices, we offer tailored quality support services to meet your specific needs. 

Regulatory Compliance: Our regulatory experts provide ongoing assistance to ensure compliance with ISO standards, FDA regulations, EU MDR, and other relevant requirements. 

QMS Optimization: We help optimize your Quality Management System for efficiency, effectiveness, and continuous improvement. 

Risk Management: Our team assists in identifying, assessing, and mitigating risks following ISO 14971 guidelines. 

Document Control: We streamline document management processes to support regulatory compliance and product quality. 

Continuous Improvement: We drive excellence through CAPAs, internal audits, and management reviews to ensure ongoing compliance and effectiveness. 

Why Us: 

  • Expertise: Our seasoned professionals have extensive experience across all device classes. 

  • Customized Solutions: Tailored approaches meet your organization's specific objectives. 

  • Commitment to Excellence: We are dedicated to delivering exceptional service, providing peace of mind and confidence in your product quality and regulatory compliance efforts. 

Partner with TDP for excellence in Ongoing Quality Support. Contact us today to support your organization's success. 

Book a 30 min consultation to discuss your needs.

Training and Educational Services

TDP is your trusted partner for comprehensive training in ISO 13485, ISO 14971, MD SAP, FDA Regulations, EU MDR, and all aspects of medical devices. Our programs equip your team with the knowledge and skills needed for regulatory compliance and enhanced product quality. 

Training Highlights: 

  • ISO 13485: From fundamentals to QMS implementation, our training ensures compliance mastery. 

  • ISO 14971: Learn risk management principles and best practices for effective risk mitigation. 

  • MD SAP: Navigate global regulatory audits with confidence through our comprehensive training. 

  • FDA Regulations: Gain insights into key FDA requirements for market access and compliance. 

  • EU MDR: Prepare for regulatory changes in the EU with detailed training on new requirements. 

  • Medical Devices: Tailored training covers development, manufacturing, quality assurance, and compliance. 

Why Us: 

  • Expertise: Industry experts deliver practical insights and guidance. 

  • Customization: Programs are tailored to meet your organization's specific needs. 

  • Interactive Learning: Engaging sessions include real-world examples and exercises for enhanced learning. 

Partner with TDP for training excellence. Contact us to learn more about our programs and support your organization's success. 

Contact us today to discuss your bespoke and routine training needs.

Or purchase our training resources

 

 AFFILIATIONS

CLIENT FEEDBACK

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company