Product Resources takes Regulatory Compliance very seriously.
New product innovation can be a very exciting and satisfying endeavor, but at some point, someone needs to get serious.
Someone needs to take a realistic, cost-focused look at the design, engineering and manufacturing process. Someone needs to do the work of preparing the necessary documents and procedures to ensure consistent production output.
And someone needs to give serious consideration to regulatory compliance – to make sure the product is built to satisfy all regulatory standards.
Product Resources has the experience to bring your next product through the design, engineering and manufacturing process with confidence.
We are an ISO-certified product development company
Recognizing the importance of quality, Product Resources has earned and maintained the following quality certifications:
- ISO 9001 – approved for engineering design, development, manufacturing and service – certified by TUV.
- ISO 13485 – approved for medical device manufacturing and service – certified by TUV.
- ISO/IEC 80079-34 – approved for engineering design, manufacturing and service, audited by TRaC Global, for equipment and instrumentation used in explosive atmospheres.
We help our clients with all applicable regulations – worldwide
Every design and development project needs to move forward with one eye steadily focused on the appropriate regulatory requirements.
Which requirements you face will depend on your product and where you plan to distribute it.
Our team has experience with regulatory agencies from all parts of the globe. We work in accordance with all major industry standards, including:
The ATEX (from the French term, ATmosphères EXplosibles) Directive is the recognized safety standard for engineering design and manufacturing of products used in explosive atmospheres. This European standard is commonly applied to products used in oil and gas exploration, coal mining or any workplace where flammable gases and vapors are routinely released. Learn More.
The EMC (Electro-Mechanical Compatibility) Directive focuses on the electro-mechanical emissions from electrical and electronic products. The Directive establishes a standard for acceptable EMC levels for both emissions and susceptibility for a particular product. Learn More.
The CE (from the French term, Conformité Européene) Marking is a key indicator of a product’s compliance with European Union (EU) health, safety and environmental regulations. If you are planning to sell in Europe, you will want to have CE Marking approval. Learn More.
UL (Underwriters Laboratories) Standards are used to assess product safety testing and certification in the United States and Canada. UL is accredited by the American National Standards Institute (ANSI)
FM (Factory Mutual) Approved is a certification for manufacturers of fire protection, electrical equipment and building materials. The certification is provided by FM Approvals, an international leader in third-party testing and certification services.
TUV (from the German name, Technischer Überwachungsvereins) is the product safety and quality certification standard from Germany. Because of its rigorous requirements, it is often viewed as the international benchmark for product safety compliance.
FDA (Food & Drug Administration) is a United States government agency responsible for protecting the public health by assuring the safety of food, drugs and many other products including medical devices and products that emit radiation.
MSHA (Mine Safety and Health Administration) is a United States government agency responsible for overseeing mining practices and mining workplaces in the United States. The goals of MSHA are to prevent death, illness and injury in mining.
CSA (Compliance Safety Accountability) is an initiative of the Federal Motor Carrier Safety Administration dedicated to promoting safety for large trucks and buses. CSA’s regulations may play a role in the transportation of products.
How we work
Regulatory compliance plays a central role in everything we do – from initial design and engineering to manufacturing and distribution. You could say it is baked into our process.
But what if you already have a prototype? What if all you need is a compliance review?
Yes, we can help. We work with OEMs, industrial design firms and engineering companies at various stages in the product development process.
Let’s talk about your next project. Please call Paul Ermanski at 978-524-8500 ext. 335 or email@example.com