Consulting

Our medical device operations consulting services are built on real-world experiences in the MedTech industry. With team members who’ve worked inside leading OEMs, our experience spans project management, production, regulatory compliance, and quality system management. We not only advise—we also roll up our sleeves and help solve real problems. Whether you’re a startup launching your first device, or an established manufacturer managing complex operational demands, we’re ready to help. As a result, we deliver strategic, practical guidance to help you move forward with confidence.

Medical Device Cleaning – Through our partnership with Ecoclean, we’re developing a dedicated Medical Device Cleaning Solutions Center. This partnership, combined with our expertise in packaging, labeling, and regulatory affairs allows us to offer comprehensive cleaning and packaging solutions.

Quality Management Systems (QMS) – With experience navigating the QMS landscape at major OEMs and developing our own ISO 13485:2016 certified quality system, we offer proven expertise in regulatory compliance. Therefore, we understand the complexities of building scalable, audit-ready systems that meet FDA 21 CFR Part 820 requirements.

Regulatory Affairs – Our team includes experienced professionals with a focus on compliance auditing, post-market surveillance, and product recalls. We help you stay in step with evolving regulations and reduce risk while maintaining product integrity.

Document Legalization – Navigating global submissions requires accuracy and attention to detail. We provide comprehensive document legalization services for global submissions. We have on-site notaries to facilitate this process.

Project Management – From new product introductions to cross-functional initiatives, we offer practical, hands-on support to keep projects on time and aligned with business goals.

Validation – Our team includes experienced engineers with a track record of successful process validations across a variety of manufacturing operations and quality systems.

In summary, whether you’re refining a process, preparing for an audit, or launching a new product, EnPak provides medical device operations consulting that’s grounded in experience and focused on results.