A Medical Device is as good as its parts, this eventually makes supplier qualification process extremely important in Medical Device Design & Development. FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4 highlights major requirements for purchasing controls and evaluating suppliers. Missing a single step in the supplier evaluation or qualification process can ruin the entire process and incur losses. Here, we highlight 5 key hacks that we adopt in our supplier qualification process to deliver quality projects within deadlines.

6 key hacks of supplier selection & qualification process for Medical Devices

1) Do not assume one supplier is good for all the requirements

It’s necessary to understand that one supplier who is good for a specific component or part, might not be a good fit for delivering other components. Every project has several specific requirements. Assuming that a single supplier has everything for all projects is irrelevant. It’s necessary to have a network of suppliers to reduce dependencies. With 400+ suppliers in our network, we make sure we choose the best for your specific requirement.

2) Fix a protocol and do not skip any step

We adopt a fixed protocol which involves virtual & physical audit for most of the suppliers. It is due to the efficiency of these processes; we’ve successfully fulfilled numerous requirements even during crisis.

 3) Adhere to mandates by FDA 21 CFR 820.50 and ISO 13485: 2016

Eventually the product will undergo FDA approval process. We make sure our evaluation processes are in sync with FDA guidelines to ensure we have all the documents (DHR) that our clients will need to take their products to global markets.

4) Checking on key traits of a good supplier

A good supplier has some basic traits that a manufacturer must evaluate on the first hand.

These include:

  • A reasonable response time: A good supplier will give you a reasonable timeline for delivery. He /She will not give you false hopes and unrealistic timelines
  • A good past record: Credibility is not achieved in a day, it’s the outcome of a successful long business relationship. Checking the past record of a supplier can help you evaluate whether he/she will be able to cater to your requirements or not
  • Transparent Communication: A good supplier will communicate with you about everything, even the hurdles. They won’t become a roadblock; they’ll tell you if there is some major hurdle which might cause a delay

We evaluate basic traits first to make sure we don’t sign up for wrong suppliers who unnecessarily cause delay and impact project timelines.

5) Choosing suppliers closer to manufacturing location

Don’t go with preset notions! Instead make your purchase team do that hard work of finding suppliers closer to the manufacturing destination. Having a closer supplier can potentially bring down the cost.

6) Continual monitoring & evaluation

While creating BOM we pick out the points that require continual monitoring and evaluation. This ensures minimal errors, immediate reporting & correction with minimal hassle.

How to manage your Medical Device Suppliers?

Medical Device Manufacturing companies need to build trust with supplier. It’s a two-way relationship built on transparent communications. Few measures we adopt to ensure strong Medical Device Supplier relationships are:

a) Placing bulk requirements even when not required

Sometimes medical device manufacturers show urgency even when it’s not there. When they don’t follow up at the same pace the supplier understands that it wasn’t a priority. This can lead to conflict and loss of credibility. We make sure we evaluate our priorities beforehand and place requirements accordingly.

b) Do not call for SCAR until a component puts quality and safety of the user at stake

SCAR (Supplier Corrective Action Request) at the supplier’s end is similar to CAPA (Corrective Action Preventive Action) for a Manufacturing facility. It involves a lot of work and entire team involvement. Until the component or part does not impact quality of the project it should not be the reason for SCAR. However, if the repercussions are major, a manufacturer must ensure implementing SCAR.

Sign up with Johari Digital Healthcare for Cost Optimized & Regulatory Compliant Manufacturing services

Johari Digital Healthcare Ltd. is a global Medical Device Manufacturing organization with 40+ years of expertise. Our global authenticated supplier network across multiple geographies assures accelerated Go-To-Market of Medical Devices. Our manufacturing services span across multiple segments including life sciences, diagnostics, clinical lab equipment and more.



Error: Contact form not found.


Project Quote / Consultation Request


    Catalog Download

    Error: Contact form not found.