Benefits of Medical Devices ISO 13485
This globally recognized model provides a validated quality control mechanism methodology that makes for a system that satisfies regulatory requirements. ISO 13485 provides a comprehensive overview of regulatory requirements and is therefore recognized worldwide and some countries have even made it compulsory for medical device manufacturers to acquire it.
ISO 13485:2016 Quality Control Programs for Medical Devices establishes specifications for companies across all areas of the lifecycle of medical devices, covering both the commodity and associated facilities. Through introducing a formal system that aligns with the business’ strategic direction, organizations will experience:
Benefits include:
Meets delivery criteria
Create faith and trust with customers by putting in place a realistic process for fulfilling the regulatory criteria for a quality control program for medical devices.
Earn entry to business
Whether you’re a medical equipment maker at every point of the lifecycle, or a retailer, ISO 13485 brings you universal certification for quality control programs. ISO 13485 ‘s framework and principles lie at the core of additional regulatory requirements such as the Single Audit Program for Medical Devices (MDSAP).
Pushes Company Success
Align your management system with your organization’s strategic direction to improve process efficiency while minimizing reputational risks.
Improve patient safety and improved quality
Secure patient health by rigorous risk control across the entire lifecycle of medical devices incorporated in each operation.
No matter the business the company is in, what counts most is customer service. The ISO 13485 system is founded upon a collection of standards of voluntary consistency. One of the main values is ensuring consumer loyalty. By periodically evaluating consumer expectations and adjusting the deals accordingly, you will satisfy customer requirements as well as achieve customer loyalty. Current customers are very conscious or regulation. They wouldn’t always tolerate a manufacturer who isn’t ISO 13485-certified. In addition, customer satisfaction does help you to transform your clients into loyal and permanent customers.
Upon learning all of the benefits from ISO 13485 certification, you should consult with an ISO consultant who is skilled and knowledgeable. No one can do better than ISO Pros when it comes to our ISO 13485 Consultants. Why are you choosing us? Well, there are several reasons why you should be partnering with us, for example:
Cost
We ‘re committed to delivering premium quality assignments at a surprisingly affordable fee to meet your specific requirements! Nothing else will give you quality at a very reasonable price, just the way we always do!
Speed
While other companies have long waits for their ISO certification with a sense of doubt and anxiety, we feel their discomfort. ISO Pros will plan for your company, so you can complete the full certification phase within as little as 90 days, tops.
Ample Resources
ISO certification isn’t only a very lengthy process, yet it also needs tons of resources to make it even more difficult. If your principal problem is a shortage of resources, put it on us. ISO Pros has a range of trained and knowledgeable ISO experts who can quickly satisfy the ISO 13485 specifications.
Quality
With ISO Pros, our team of experts believes in the full power of a very lean consultancy approach that helps all our clients to maintain ISO certification validity. After you’ve contract our staff, you won’t need to employ any contractors to constantly track and evaluate the program to ensure the consistency and comply with the norm. Even after we get the certification, we are there for you.
There are several distinct benefits that you should anticipate from hiring a company like ISO Pros to handle your certification:
- A full understanding of the ISO 13485 specifications. We will clarify and direct you on how the product ‘s performance would be impacted by the regulations.
- Documentation procedures are strictly controlled and we keep product documents, including all components and materials used for manufacturing, existing, correct, and recoverable.
- Under the guidelines of the medical device sector, manufacturing and test procedures are straightforward and readily auditable.
- Experience in assisting many companies who are producing many forms of pharmaceutical items. Attaining ISO 13485 certification indicates that your company is a leader in medical devices.
- Partnerships with manufacturers of products which also meet with the safety standards of medical equipment, guaranteeing the highest level of quality in the manufacture of your medical device.
Frequently Asked Questions
We are a small company, and new to the process of certification. Our customers require, in a very short time, for us to obtain certification; can ISO Pros help?
Business size doesn’t matter because whether it’s a small or big company; they all meet the same certification requirements. Within the scope of realistic feasibility research, ISO Pros uses all tools at its disposal to fulfill the deadlines provided by your client. Certification bodies, however, generally require a minimum of 3 months of certification data. ISO Pros also leaves no stone unturned to reach the goal deadlines, dependent on the availability of Recognition bodies.
What Classes used for all Medical Devices
Medical devices can generally be classified into Class I and Class II as well as Class III categories
- Class I are Medical Devices that has no contact with human/animal or very short communication such as stethoscope or bedpan etc.
- Class II are medical devices that can be used in this group as tools that have contact with a human body for no more than twenty-four hours, such as Crutches and Teeth Braces for example.
- Class III can be the tools that have permanent human body touch, like implantable devices which include implanted joint parts, speed drivers, dental implants, and more.
Compliance with regulatory requirements is a guideline for medical device manufacturers or suppliers who are looking for opportunities to reach new markets. If you are one of those businessmen who want to take advantage of the cost advantages in the manufacture of medical equipment, then ISO 13485 qualification is an excellent option for you!
Thinking of becoming certified according to ISO 13485? We’re a phone call away!