Regulatory Compliance

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.

CLASS 1

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
CLASS 2

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)
CLASS 3

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)
MDD/MDR
CSA/UL

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,Class II, and Class III, taking them from concept to market entry, and passing all regulatory hurdles. Here are a few of those projects – see our portfolio section for more.

Company	510(k) Number	Classification	Medical specialty
Transviso Inc.	K080650	Dialyzer	Gastroenterology/Urology
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:

Wearables
Implants
Digital Health
Cyber Security
Human Factors
Product Lifecycle Management
UDI
21 CFR 820, 21 CFR Part 11 (820 is quality systems, and part 11 is electronic records and signatures)