Author: Anne Holland, CEO and Founder
When medical device companies are looking to purchase supplies or services, it’s a no-brainer they’ll use a company from their approved supplier list. But what exactly is an approved supplier?
Essentially, an approved supplier is an entity that a company has deemed fit to provide supplies or services based on various criteria such as quality, certifications, and price. Companies will then compile these various suppliers and service providers they’ve approved into an easily accessible list.
QA Consulting is on the approved supplier list for many leading multinational medical device companies, which is no small feat. Approved suppliers must not only meet strict guidelines to gain approved supplier status but maintain those standards to ensure they stay on these lists.
Clients doing business with someone on an approved supplier list can be confident that, like QA Consulting, they’re:
- Qualified to perform selected services
- Trusted by companies, as well as those affiliated with them
Qualified and Certified Expertise
When a supplier or provider is on an approved supplier list, whether it’s for a large company or a small company, they’ve proven they’re qualified to perform work according to the company’s standards. Each company has specific criteria they’re looking for to ensure a potential supplier is qualified. Some organizations will ask for documentation such as a resume/CV, survey, or credentials list, and some may ask for a full-blown audit.
One certification that makes qualifying for approved supplier status much easier is the ISO 13485 certification. Holding this certification means a company has demonstrated the ability to provide services, custom components, or materials in one or more stages of the medical device lifecycle that continually meet customer and applicable regulatory requirements.
As an outside service provider, the standards are often harder to achieve than for someone working internally. For example, an employee at a company could potentially execute an internal audit without significant training. However, for an outside organization such as QA Consulting, we need to prove we’re qualified to perform the services for which we are hired.
QA Consulting is ISO 13485 certified for medical device consulting services for quality management system implementation and maintenance, regulatory affairs, and microbiology. Additionally, we’re WBENC and HUB certified, which also helps us qualify as an approved supplier for leading medical device companies.
Because we’re ISO 13485 certified for multiple scopes of practice, we can work with a comprehensive “all-in-one” approach—leading to faster solutions for our partners. In niche areas such as quality and regulatory services, many organizations don’t have their own in-house expertise. This allows us to come in as an approved supplier to support an organization’s quality, regulatory, and microbiology needs in addition to other needs that may arise.
An example of QA Consulting’s ability to provide a comprehensive “all-in-one” approach is when a client had a product held up in international customs. We developed a plan on the regulatory and quality side to clear their product and assist with submissions. QA Consulting has expertise in both US and international submissions and 510(k) premarket notifications.
Once a supplier or provider has proven they’re qualified and placed on the approved supplier list for a specific organization, they’re often trusted to work for other locations or sister companies. Many companies have approved supplier lists vertically and/or horizontally integrated across the organization.
As an example, QA Consulting was asked to perform an audit for a European division of a company we work with in the United States. Because we’re on the company’s approved supplier list, it was easy for an international department to utilize our services and have confidence in our qualifications and ability to provide a high-quality experience.
Another benefit companies often gain from having approved suppliers is negotiated pricing. This promotes trust between a company and their approved suppliers—the company trusts they’re getting a fair price for the services they need and suppliers trust they’ll receive a steady stream of business.
Lean Into Our ISO 13485 Certified Expertise
Partnering with an organization that is ISO 13485 certified to provide you with knowledge from qualified professionals and trusted experience in every step of the medical device journey—consulting and outsourcing, industry protocols, procedures, and regulatory updates—is invaluable.
Leverage the knowledge of QA Consulting’s qualified experts’ breadth and depth at any point in your product’s lifecycle.