Regulatory Strategy & Submissions

TPL provides comprehensive regulatory strategy support to help medical device companies navigate complex global approval pathways. Services include regulatory assessments, classification and pathway determination, pre-submission planning, and preparation of regulatory submissions such as FDA 510(k), PMA, De Novo, and international submissions under EU MDR and other global frameworks. TPL works closely with clients to align technical documentation, clinical evidence, and testing strategies to ensure efficient and successful market entry.

Audits & Inspection Readiness

TPL conducts internal audits, supplier audits, and mock regulatory inspections to prepare organizations for FDA, MDSAP, and ISO audits. Services include audit planning, execution, reporting, and remediation support. TPL focuses on building audit-ready systems that minimize regulatory risk and improve organizational confidence.

Quality Management Systems

TPL designs, implements, and improves quality management systems that meet regulatory requirements and support scalable business growth. Services include ISO 13485 and MDSAP implementation, FDA QSR compliance, quality system remediation, and documentation development. TPL helps organizations build practical, sustainable quality systems that not only pass audits, but also enhance operational efficiency and product consistency.

Manufacturing & Process Validation

TPL provides manufacturing readiness support, including process development, equipment qualification (IQ/OQ/PQ), process validation, and supplier qualification. Services focus on ensuring manufacturing processes are controlled, repeatable, and compliant with regulatory requirements. TPL helps bridge the gap between design and production, reducing risk during scale-up and commercialization.

Regulatory Remediation & Gap Assessments

TPL performs detailed gap assessments of regulatory and quality systems to identify compliance weaknesses and improvement opportunities. Services include documentation reviews, system evaluations, and corrective action planning. TPL works with clients to implement practical remediation strategies that restore compliance and prevent future issues.

Design Control & Risk Management

TPL supports design control activities throughout the product development lifecycle, ensuring compliance with regulatory expectations while maintaining flexibility for innovation. This includes development of Design History Files (DHF), risk management processes in accordance with ISO 14971, usability engineering, and verification and validation planning. TPL helps clients manage technical risks, maintain traceability, and demonstrate product safety and performance.

Post-Market Surveillance

TPL develops and supports post-market surveillance systems to ensure ongoing regulatory compliance and continuous product improvement. Services include complaint handling systems, vigilance reporting, CAPA programs, post-market surveillance plans, and periodic safety update reporting. TPL helps clients proactively manage product performance and regulatory obligations throughout the product lifecycle.

Product Lifecycle Strategy

TPL provides strategic consulting across the entire product lifecycle, from early concept development through commercialization and post-market management. Services include product roadmap development, regulatory planning, risk mitigation strategies, and lifecycle optimization. TPL acts as a long-term partner, helping clients align regulatory compliance with business objectives and market success.