Total Product Lifestyle

Darci Diage is the Founder and CEO of TPL Consulting (Total Product Lifecycle Consulting), a firm dedicated to guiding medical device companies from concept to commercial success. With over 20 years of experience leading complex laboratories and quality departments, Darci combines deep technical expertise with strategic insight to accelerate product development and market approval.

At TPL Consulting, Darci helps clients navigate every stage of the total product lifecycle, providing services that include:

  • Product design and development strategy – transforming innovative ideas into feasible, compliant medical devices

  • Regulatory compliance and quality systems – ensuring adherence to FDA and international standards, including design controls and risk management

  • Manufacturing and commercialization planning – guiding scalable, safe, and efficient production

  • Regulatory submission support – assisting with filings for approvals in the U.S., EU, Canada, and Australia

Darci’s experience spans a wide range of medical technologies, including cardiovascular devices, combination products, spinal implants, and software-driven medical devices. Her extensive background in feasibility testing, design control, and risk management has enabled the successful launch of numerous devices in highly regulated markets.

Holding a BS in Molecular Biology and an MS in Biomedical Laboratory Science, Darci brings a rare combination of scientific knowledge, regulatory expertise, and operational leadership to every project. She is passionate about helping medical device innovators turn complex challenges into successful, compliant products.

MDSAP and ISO 13485:2016 internal auditing is critical for medical device companies seeking to maintain regulatory compliance and operational excellence across global markets. These audits ensure that quality management systems meet international regulatory requirements, including those of the FDA, Health Canada, and other participating authorities, while supporting consistent product quality and patient safety. Implementing effective internal audits helps organizations identify risks, close compliance gaps, prepare for regulatory inspections, and drive continuous improvement. Ultimately, strong internal auditing under MDSAP and ISO 13485:2016 strengthens regulatory readiness, reduces business risk, and builds confidence with regulators, partners, and customers.

EU MDR (European Union Medical Device Regulation) compliance is essential for medical device companies seeking to access and remain in the European market. It ensures that products meet the highest standards for patient safety, clinical performance, and regulatory oversight, while supporting CE marking and long-term market approval. Achieving EU MDR compliance also strengthens regulatory credibility, reduces business and compliance risk through robust quality and post-market surveillance systems, and builds trust with customers, partners, and regulators. Ultimately, EU MDR is not just a regulatory requirement, but a strategic investment in product quality, global expansion, and patient confidence.