Which FDA Classification is Your Product?
DeviceLab is a design firm, not a regulatory consulting firm. We don’t take projects where regulatory consulting is the only service. We are committed to compliance in our operations and deliverables and maintain an in-depth knowledge of standards and regulations. So if DeviceLab designs your device, we’ll make sure you achieve regulatory compliance and can demonstrate it. We work with outside regulatory partners to handle things like clinical trials and submissions.
Some of our competitors in the design space don’t fully support compliance, which can cause problems bringing products to market such as test failures, inability to complete V&V, rejected regulatory submissions, and back-and-forth delays.
examples: stethoscopes, bandages, wheelchairs
Low risk devices that are simple in design
Self-register product with the FDA
Most are exempt from pre-market requirements
QMS normally comply with 21 CRF Part 820 General Controls, though some devices are exempt
examples: ultrasonic diagnostic equipment, x-rays, needles
Medium risk devices that are more complex in design
510(k) pre-market approval process is required for most
QMS must comply with 21 CFR Part 820: Special Controls (Design Controls)
examples: balloon catheters, pacemakers, heart valves
High risk devices
FDA shall inspect facility
QMS must comply with 21 CFR Part 820
Clinical trials likely
Malfunction is absolutely unacceptable
Start-To-Finish Compliance Experts
We can help you establish appropriate user needs and smart design inputs that incorporate all regulatory requirements and facilitate V&V. As we develop your device, we produce comprehensive design output documentation.
This preparation speeds verification and validation because criteria and evidence are clear, and risks have been identified and mitigated. Building on this strong base, DeviceLab’s help with transfer to manufacturing and regulatory approval activities assures that you can market your product on schedule.
Registered Quality Management System
DeviceLab has a registered quality system compliant to ISO 13485 and 21 CFR 820. We’ve held QMS registrations since 2005, with a record of clean audits. Our Risk Management procedures are compliant with ISO 14971, and our Software Lifecycle Processes are compliant with IEC 62304. Our QMS registrar is ASR, one of the leaders in medical quality systems assessment. Beware of providers who claim to provide regulatory support, but don’t have a registered QMS in their company.
See our QMS certificate here
Applying All Required Standards
DeviceLab also complies with the standards applicable to the products we develop to ensure your product is fully compliant. Here’s a partial list (others may apply in specific instances):
- IEC 60601 and 80601, Medical Electrical Equipment
- IEC 62366, Usability Engineering
- ISO 10993, Biocompatibility
- IEC 62304: Software lifecycle
- IEC 62366 and IEC 60601-1-6: Usability
- IEC 60601-1-2: EMC
- IEC 60601 series: Medical Device Safety
- IEC 61010 series: Laboratory and IVD Safety
- IEC 61326 series: Laboratory and IVD EMC
- ISO 14971: Risk Management
- IEC 60825: Lasers
- RoHS, Reduction of Hazardous Substances
- FCC (47 CFR Part 15 & 18), Radio Frequency Devices
- Radio Equipment Directive (RED)
Compliance Starts With People
DeviceLab employees are fully trained in compliance with QMS standards and product-specific standards in their areas of expertise. Our experience in developing medical devices over a range of technologies and applications has taught us how to execute compliance activities (e.g., risk assessment, safety testing, sterilization validation) quickly and efficiently.
Our Track Record In Compliance
DeviceLab has over 20 years’ experience developing medical devices ranging from Class I through III, from concept to market entry, passing all regulatory hurdles. Here are a few of those projects – see our portfolio section for more.
|Company||510(k) Number||Classification||Medical specialty|
|WNT Inc.||K091538||Pressure Release Valve _ Audible||Anesthesiology|
|WNT Inc.||K111191||Pressure Release Valve _ Humidifier||Anesthesiology|
|LenSX Inc.||K161288||Ophthalmic Femtosecond Laser||Ophthalmic|
|Alcon Laboratory||K021566||Phacofragmentation Systems||Ophthalmic|
|LED Intellectual Properties LLC||K153399||Lamp, Infrared, Therapeutic Heating||Physical Medicine|
|LED Intellectual Properties LLC||K151336||Light Based Over The Counter Wrinkle Reduction||General & Plastic Surgery|
|LED Intellectual Properties LLC||K151333||Lamp, Infrared, Therapeutic Heating||Physical Medicine|
|Eigen||K162474||System, Image Processing, Radiological||Radiology|
|Intralase Corp.||K041893||Powered Laser Surgical Instrument||General & Plastic Surgery|
|Intralase Corp.||K073404||Powered Laser Surgical Instrument||General & Plastic Surgery|
|Intralase Corp.||K063682||Powered Laser Surgical Instrument||General & Plastic Surgery|
Controlling the costs of Compliance
There are many paths to compliance in the design of a device, but the costs can differ widely based on the particulars of the design (e.g., doing things in software or hardware) and how successfully one can argue for the appropriate level of regulatory rigor (especially in software).
A DeviceLab design can ensure you don’t pay too much or get bogged down in needlessly tedious paperwork.
We Are Up-To-Date With Guidance
DeviceLab pays attention to the evolving regulatory landscape and technical developments in medical devices to ensure that we’re ready for the latest product ideas. Some of the areas we follow closely are:
- Digital Health
- Cyber Security
- Human Factors
- Product Lifecycle Management
- 21 CFR 820, 21 CFR Part 11 (820 is quality systems, and part 11 is electronic records and signatures)