This standard adopted the prevision ISO revision (ISO9001:2008). It does have risks, process approach and new definitions, However, it has a lot of required procedures and records with the following terms: Control of documents; Control of Records; Control of Nonconforming Product; Corrective Action; and Preventive Action.
For this reason, it is important that manufacturers of medical devices address compliance with the requirements of the applicable Medical Device Directive and the CE marking process (Conformité Européenne) before placing their products on the European Union market. Medical Device Manufacturers must comply with 21 CFR 820.
Do you need the services of a professional ISO 13485 Consultant? In case you are in search of dependable ISO 13485 Consulting agency to ensure that the medical devices designed and manufactured by your organization meet the ISO 13485 standard, QARMA Consulting remains the perfect fit to get the job done. We are a top notch ISO 13485 Consultant renowned for providing outstanding services when it comes to monitoring, checks, maintenance, inspection, and controls.
What We Do - ISO 13485 Certification Process
QARMA Consulting is a consulting agency offering first class ISO 13485 consulting services. All our operations are dedicated towards ensuring that the medical devices manufactured and designed by your company comply with the requirements of the applicable Medical Device Directive and the CE marking process.
Our team of proficient consultants at QARMA Consulting will carry out a well-detailed observation of your existing quality system. Even the slightest details will not be overlooked as we look for shortcomings and risks, while we map your system to the ISO 13485 standard.
After observing your system, we will also offer suitable suggestion and implement modifications that will help improve your processes. We can also help you with documentation and controls. In addition, we can guide you through the procedures involved in your ISO 13485 certification.
Why Choose QARMA as your ISO 13485 Consultant
QARMA Consulting is really concerned about your organization and those making use of your medical devices. Our team of knowledgeable consultants with hands-on experience will provide you with useful suggestions and tips to help improve the design and manufacture your medical devices. We will also help you monitor customer feedback and maintain system effectiveness.
100% Track Record. We Make It Easy For You.
Furthermore, QARMA Consulting will also make the certification process easy & simple for you. We have a 100% proven track record for completion of successful certification for all companies who have utilized our consulting services in the past. You can always count on us for your ISO 13485 consulting.
Reach Out To Us!
You need to hire the services of a professional ISO 13485 consultant to ensure that the design and manufacture of your medical devices are uniform and also meet up with industry standards. QARMA Consulting is always ready to help you.
100% Track Record.
We Simplify the Process.