services
Testing
Our engineering team and network of industry professionals can assist you with testing for engineering for prototypes to certification testing.
Our engineering team and network of industry professionals can assist you with testing for engineering for prototypes to certification testing.
If your needs are troubleshooting leakage current problems or defining verification parameters for specialized equipment we can perform testing and assist you in defining requirements. Meeting the test thresholds in 60601-1 is a presumption of conformity with the MDR essential requirements and aligns with the FDA recognized consensus standards demonstrating basic safety.
90 Seconds About Us
Device Conformity and Testing LLC is a new consulting firm and testing laboratory located in Devens, MA. Since January 2018, they have been helping clients with all aspects of safety compliance.
Device Conformity and Testing LLC acquires the test equipment, standards catalog, and customer information of O’Brien Compliance Management.
“I’ve worked with Gregg over the years and know him to be one of the finest compliance engineers. I’m thrilled to see Gregg carry the safety mission forward. I’ve told him I’m available to help smooth any transition issues for those customer choosing to continue working with Device Conformity and Testing
Consulting
We can help with all aspects of safety compliance and be your go to expert for issues that may arise.
Testing
Our engineering team and network of industry professionals can assist you with testing for engineering for prototypes to certification testing.
Field Evaluations
The technical requirements used to evaluate products consist of the applicable parts of the National Electrical Code (NEC).
Links
Location
Office94 Jackson RoadSuite 211Devens, MA 01434
Contact
Gregg Edwards
Phone: 978-697-4665
Email: gedwards@devconform.com
Gregg Edwards
Phone: 978-697-4665
FAQs
What are your services?
Based in Devens, MA, Edwards Medical Testing performs all aspects of
medical testing. Our capable and knowledgeable technicians provide industry-standard testing for your
medical equipment
and devices. You simply won’t find better, more thorough testing services anywhere!
Our company has a special focus on IEC 60601 series electrical medical equipment and IEC 61010 Series Electrical Equipment for measurement, control, and laboratory use. We are experienced in performing partial or limited testing for new prototypes, where verification testing of initial design options can assist in early design decisions. Our team wants to help you create the absolute best, most effective, and most precise equipment possible. We do this through our meticulous testing processes right from the beginning of your equipment’s design process. We can perform testing to appropriate safety and performance
consensus standards, or we can help you tailor a test procedure and test form for your specialized verification needs. Gregg Edwards provides the highest standard of testing on the market, and we deliver it all with unmatched customer service.
When you give us a call, you’ll be connected directly to one of our friendly staff, so you can expect immediate attention to your inquiry.
Where do I go to pay for services?
To pay for services, go to the 'Pay' tab and insert your personal information along with the total cost of services that we discussed over the phone or email. You must contact Gregg Edwards to discuss costs and what services you need. All payments will be fulfilled online.
What is medical equipment testing?
New medical devices and equipment must undergo a certification process in order to be used. First, your medical device has to be classified under one of the four classes (I, IIa, IIb, III). The class your medical device falls under states how much risk your device can carry. The classes range from low to high risk. The classification of your medical device will be determined based on the following factors: period of continuous use, whether it is surgically invasive, whether it is an implant or active device, and whether the medical device contains a clearly defined medicinal substance. With this, the Intended Purpose of Use will also effect the medical device's classification.
Let Device Conformity and Testing LLC test your medical equipment for you and make sure it has proper certification. Medical equipment is crucial in hospitals and clinics to save lives. These medical devices allow medical professionals to assess a patient's conditions and save lives. We want to make sure your medical devices are working at optimal performance and are safe to use. So, don't wait. Call Device Conformity and Testing LLC now!
Importance of medical device compliance.
Medical device compliance is very important for your business to succeed. First, medical device compliance ensures that your medical devices and equipment are safe for patients to use. The goal of medical devices is to help treat patients. However, if you do not have medical device compliance, your product can do more damage than good. Acquiring medical device compliance can be easily done by doing things such as creating a traceability matrix and detecting errors early on in the development process to help save on costs in the long run. Make sure to get your medical device testing done as soon as possible! It is important that you receive FDA compliance approval to avoid any penalties. Additionally, your business will be faced with several audits. Therefore, if your devices meet compliance regulations, the audit process will go much more smoothly and you will avoid unwanted fines and penalties.
What is IEC 61010-1?
IEC 61010-1 (International Electrotechnical Commission) addresses safety requirements for many electrical systems. By following guidelines and meeting the required standards, hazards can be minimized. This certification is required for all medical devices and equipment.
What are the different types of medical equipment?
There are many different types of
medical devices
that are used for different purposes in treating patients in a medical setting. Below are the different types of medical devices and what they are most commonly used for.
Diagnostic Equipment
Diagnostic equipment is any device used for diagnosing a patient's condition. Some of the most common devices include patient scales, stethoscopes, dopplers, and pulse oximetry. The more advanced pieces of diagnostic equipment are medical imaging machines which are used to look inside the patient's body to make a diagnosis. Types of medical imaging machines include radiography (X-ray machine), computed tomography (CT scan), magnetic resonance imaging (MRI scan), and ultrasounds.
Durable Medical Equipment
Durable medical equipment are devices used to provide therapeutic benefits. These devices are usually long-term and reusable. As the name implies, durable medical equipment provides mobile assistance for patients going through physical therapy, for example. Therefore, some common medical devices include wheelchairs, crutches, and hospital beds. However, durable medical equipment can also include devices such as breast pumps, stationary or portable oxygen tanks, insulin pumps, and ventilators.
Treatment Equipment
Treatment equipment is designed to treat a specific condition using modern technology. Common pieces of treatment equipment include infusion pumps, medical lasers, and LASIK surgical machines. In addition, treatment equipment that is used in surgical procedures include diagnostic scopes, gauze, drapes, and surgical caps, gowns, and gloves.
Life Support Equipment
Life support equipment is responsible for keeping a patient's body functioning. Without it, the patient's organ systems would not be able to function on their own. The most important life support machines that are used today are heart-lung machines, medical ventilators, dialysis machines, and incubators.
Medical Laboratory Equipment
Medical laboratory equipment is common in medical clinics and diagnostic laboratories to analyze things such as blood, urine, and genes. Examples of medical laboratory equipment include blood gas analyzers, blood collection supplies, drug testing analyzers, and microbiological systems.