Medical device companies face an uphill battle regarding regulatory compliance, especially as the Food and Drug Administration ramps up enforcement efforts to ensure patient safety.
However, the best way to successfully navigate the regulatory waters isn’t necessary to hire an in-house expert — although that’s certainly an option. Instead, your best bet is to hire the services of someone who has been certified by the FDA as a Certified Medical Device Compliance Professional (CMDCP) for compliance certification.
Read on to see why you should invest in such a certification for yourself or your company:
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What is a Certified CMDCP?
Certified medical device compliance professionals are the ones who make sure that medical devices comply with regulations. They work closely with regulatory bodies and manufacturers to help ensure that all products are safe for use.
CMDCPs are valued employees in the healthcare industry because they make sure that everything is on the up and up. This is an important role, as people’s lives depend on it! It’s not just about making sure there aren’t any manufacturing errors; these professionals also ensure the marketing claims are accurate and follow strict guidelines.
Furthermore, they need to know how product recalls should be handled when something goes wrong so that the company doesn’t face more legal trouble than necessary.
These critical responsibilities mean that you need someone well-versed in compliance standards and a thorough understanding of what needs to be done to achieve success – no matter how difficult or challenging the circumstances may be.
A CMDCP will go above and beyond what is required by law so that no stone goes unturned. If you’re interested in hiring one of these individuals, pick a reliable company for the task.
How Do You Become A Certified CMDCP?
If you want to become a certified compliance professional, you must first meet the eligibility requirements. The applicant must at least undertake a program and have an associate degree or higher.
They also need some years of experience in a medical device company or related field. If you do not meet these qualifications, there is no need for concern! You can enroll in an online training course where you will learn how to comply with the set standards. Upon completion of the course, you will be eligible for a certification exam. Once this is completed, you can apply for your CMDCP certificate.
How to Choose a Good CMDCP Certification Company
Choosing the right certification company can be difficult. Here are some questions to help you make your selection.
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What is the cost?
A CMDCP certification is not cheap, and it shouldn’t be. You want to know what you’re paying for, so don’t base your decision on price alone.
Some companies charge more but offer more exams or more hours of training, whereas other companies may offer fewer exams but at a lower cost. It’s important to compare all aspects of each program to find the best value for your time and money.
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Is the company easy to contact?
Before you spend any money on a program, you should be able to get in touch with the person who runs it. All good certification companies should have an email address and phone number listed somewhere on their website.
If they don’t answer the phone when you call, that’s probably not a good sign. The last thing you want is to pay for a service and then never hear from them again.
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Does the course provide results?
Just because someone passes a CMDCP exam doesn’t mean that they actually learned anything. Look for programs that provide test scores and exam percentages as evidence of learning; if the company isn’t willing to share this information, move on.
Remember that everyone learns differently, so only you know how well you need to do on an exam before you feel confident about passing. If you don’t think you’re ready, take another course and try again until you feel confident about your ability to pass the exam; remember, if it is too hard or too easy, it might not be worth taking at all.
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Is there someone available around-the-clock?
There will be times when you’ll have trouble getting through to customer support over the phone or through email (maybe even after business hours). Make sure that whatever company you choose has a knowledgeable staff member available 24/7 by phone, chat, and email. Reaching customer support quickly will save you frustration and worry in case of emergencies.
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Do they require payment upfront?
Another bad sign is when a company requires payment up front without providing any indication of whether or not the applicant will pass. Legitimate certification companies should never ask for money without first conducting an interview with the student and gauging their knowledge level.
Even if the student plans to retake the exam, he or she should still be eligible for a refund. Most people take the CMDCP exam early in the morning (usually between 6:00 and 8:00 am), which means you’ll probably need support outside office hours.
Good certification companies will have customer support available 24/7, including weekends and holidays. No matter when you decide to study for your exam, somebody should always be on hand to help.
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Do I have access to all my resources?
Sometimes certified medical device compliance professionals use different books than the certification company. Make sure that the company you choose will let you buy your books wherever and whenever you want to.
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How does the certification expire?
When does your CMDCP certificate expire? When does your next renewal period start? Many companies have different answers to these questions, so be careful not to miss out on an opportunity or pay for something twice.
Conclusion
Any medical device company needs to have a certified compliance professional on staff. As the FDA and other regulatory bodies increase their enforcement, there will be more scrutiny of companies’ procedures. If you don’t have someone with the knowledge of how to write compliant procedures, you must get training from experts like our consultants.
