Regulatory Guidance

Producing quality medical devices is in everyone’s best interest and we know what it takes to get there. At Watershed, our team members have commercialized over 10,000 medical devices through the FDA. Whether you need help with initiating FDA required design controls or with drafting regulatory submissions, we’re here to help.

Clinical Designs for Patient Outcomes

The design of 3D printed devices presents a unique opportunity to gather pre-clinical in vitro or in vivo data to support marketing claims.

We help design for a 510(k) submission, while avoiding a full clinical trial, with proper claim construction and a complementary hazard analysis that feeds back into the design process.

Additive Manufacturing of Medical Products (AMMP)

With a vast understanding of FDA and ISO regulations, and a multitude of cleared 510(k)s and submitted FDA Pre-Submissions (with accompanying DHF’s), our Device Master File (MAF)* is ready to expedite technical qualifications, process controls, and even requalification of devices.

*Watershed Titanium Additive Manufacturing Capabilities per ASTM F3001-14, Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion

Regulatory

Not only do our Design History Files dovetail effectively into regulatory filings but our teams’ history of writing, reviewing, and submitting regulatory documents make us the perfect team to properly stage your technology for commercialization. We specialize in:

Pre-submissions
510(k) filings
GUDID registrations

The management of Fountainhead and the engineers at Watershed have given me the resources to take the final steps from an accepted device patent through FDA regulations and towards market. Such steps are critical for project and business success.

Medical Doctor
San Diego, CA

Quality Assurance / Quality Compliance

Based on extensive industry experience, Watershed works with clients through a variety of engagements to provide customizable programs that help elevate quality in the design and manufacturing processes that meet or exceed governing body standards. These engagements range from consulting and training to on-site embedding to FDA/ISO remediation solutions.

Our goal is to provide our clients with robust design, manufacturing and quality management systems that are implemented and maintained in an efficient way. Example projects include:

Manufacturing and Quality Management System Implementation
Product and Process Development
Quality Auditing
Process Development/Improvements
Verification and Validation
Corrective and Preventive Action
Statistical Techniques

When I started in this role, I was very new to auditing. Watershed was able to not only train me, but they gave me the tools I needed to excel as an auditor.

Regulatory Guidance