Pentad Design Corporation

714-259-0125

Regulatory/Safety Services

Class III Implantable Device

Case Study: Class III Implantable Device

We designed the electronics and firmware for a nerve-stimulation device that enables control of a clinically obese patient’s eating habits.

We designed a Class III prototype unit with a titanium enclosure and stimulation leads. The device is implantable and the stimulation leads attach to the vagus nerve which prompts the user to control their eating and drinking behavior. An external, hand held wand device communicates wirelessly with the implantable and enables data transfer via the wand to a PC.

For support of the PMA requirements, Pentad created and ran verification and validation test plans / hazards analysis / SRS / SDD / HSIS / trace matrix / SVaP / SVeP / dry run plans and ran full V&V.

Regulatory/Safety Services

Pentad Design develops products for many different clients and industries in compliance with the relevant requirements of each company’s Quality System.

Medical Device

Our engineers have many years of experience developing successful medical devices in conformance with the evolving worldwide medical device regulations. Pentad can help from the initial specifications through to engineering design and development, prototype verification, validation, and support of your submittal process. We work with accredited test labs to obtain the necessary regulatory, Safety, EMC, and environmental test reports. We can work with large or small clients including start-ups. Class I, II, or III; 510(k) or PMA; FDA, Canada, Europe, or worldwide; Pentad can help you develop it, make it work, obtain regulatory and marketing clearance, and support your production handoff.

Commercial Aerospace

Pentad Design has significant experience in commercial aircraft passenger cabin systems. We can help with the initial specifications, through engineering design and development, test planning, prototype verification, and final validation. We can also work within your test facilities or with accredited test labs to obtain the additional Safety, EMC, and environmental test reports.

Commercial Products

Commercial products may be developed under a wide range of Quality Systems. We can develop your product in conformance with your needs and the needs of your market. Pentad can help with the initial specifications, through engineering design and development, prototypes, testing, regulatory compliance, and support production startup.

Hazardous / Classified Locations

Pentad Design has experience developing Intrinsically Safe equipment for hazardous environments. We can help with the initial specifications, through engineering design and development, prototype verification, validation, and support the regulatory approvals process. We work with your test labs to obtain the needed Safety, EMC, and environmental test reports. We will help you develop it, make it work, and support your production handoff.

If you don’t see your service need listed, please contact us at info@pentaddesign.com or call our project management team at (714) 259-0125.