Manufacturing technical operations
Engineering, scale-up, program management
Medical device manufacturing & regulatory support
Expert services for automated assembly, packaging, and combination products—aligned with FDA and ISO standards.
Bringing a medical device to market requires more than innovative design; it demands precision execution, regulatory compliance, and scalable manufacturing solutions. Whether you're developing stand-alone devices or combination products, quality and traceability are essential in a tightly regulated global environment.
Pinnaql offers comprehensive support throughout the entire device lifecycle. This includes optimizing automated assembly lines, validating packaging, and ensuring compliance with combination products. Our team of experts in engineering, quality, and validation works to ensure that your operations are efficient, ready for audits, and compliant with FDA regulations, ISO 13485, and EU MDR standards.
Pinnaql partners with medical device innovators and manufacturers to ensure compliant, high-performance production environments:
From cleanroom design and automation to validation of assembly and packaging systems.
Cross-functional support for drug-device integration and compliance (auto-injectors, inhalers, stents)
Improve throughput, reduce human error, and strengthen traceability.
Aligning with ISO and FDA requirements through pragmatic CQV and CSV approaches.
Support for early-phase builds through commercial volume manufacturing
101 Lindenwood Drive, Suite 225, Malvern, PA 19355
9800 Crosspoint Blvd, Suite 200, Indianapolis, IN 46256