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ISO 13485 Consulting for Medical Device Manufacturing Companies
Fast-Track QMS Consultants focuses on helping medical device companies fast-track the implementation and certification of their ISO 13485:2016 quality management system.
Our QMS consultancy can also help companies that need to transition from ISO 9001 to ISO 13495, or companies that want to expand their markets into the USA or Europe and so need to meet FDA quality system regulations, or European MDR requirements. Whatever your ISO 13485 quality management system needs are, contact us and we can discuss the benefits of hiring a ISO 13485 expert.
HERE ARE SOME OF THE QUESTIONS WE MOST OFTEN HERE ALONG WITH ANSWERS:
What is ISO 13485 and why do you need it?
ISO 13485:2016 is a globally reconized regulatory and quality standard for medical device companies and is based on ISO 9001
It adopts the proces model concepts of Plan, Do, Check, Act and is designed for medical device companies of all sizes and all product classifications. ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, delivery, servicing and maintenance of medical devices that are safe and fit for their intentend purpose.
ISO 13485:2016 Certification is a requirement to market medical devices in many countries including, Europe, Canada, Australia, and also serves as the base for QMS compliance in other countries. The US FDA is also planning on adopting ISO 13485.
What benefits of having an ISO 13485 quality management system:
The value and benefits of implementing and maintaining a ISO 13485 quality management system, is not just in the meeting of regulatory requirements, but also in providing a foundational tool for a quality system that provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain product quality requirements.
It can provide improved management of processes, activities, and functions which can result in reducing costs through continued improvements.
The ISO 13485 Certificate is the globally recognized standard for quality in the medical device industry and provides the customer with added confidence that your company will provide a quality product that meets customer requirements.
How long does it take to implement ISO 13485 and become Certified:
You may hear vastly different answers from different consultants, and indeed it depends a lot on different factors, i.e.:
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Starting your QMS implementation from scratch, or have existing system, i.e. ISO 9001 (importance of a gap analysis)
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Start-up medical device company or current established company
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At what stage is the design of the medical device, and manufacturing processes
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Are experienced resources available to work on the QMS implementation
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What are the markets for the medical device and applicable regulatory requirements
In our 2 decades plus experience with implementing quality systems, the average we have seen is 12 to 18 months if experienced resources are available and the certification bodies are available on plan.
With the fast-track approach that we can provide at Fast-Track QMS Consultants, by providing our expert consulting help plus the use of our prepared documentation templates, this time to implement the QMS and achieve Certification can be reduced significantly and take only 6 to 9 months.
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MICRO CONSULTING
Our Experts provide answers and offer guidance to your questions within 48 hours for free and without obligation.
Our consulting services
We can work with your team to provide consulting services for any part of your ISO 13485:2016 Quality Management System implementation. Or we can manage the entire process from planning through ISO Certification. We can also support you for FDA medical device regulatory requirements and European MDR
The consulting can be tailored to meet your needs and our ISO 13485 experts along with our QMS document templates available for download from our Store can provide you with Fast-Track process success.
Our mission is to help medical device companies fast-track implementation of a robust and proven ISO 13485 quality management system and obtain certification. We do this by offering the experienced consulting services and quality document templates that will meet our client’s needs.
Gap Analysis Planning
Completing a gap analysis and developing the ISO 13485 quality management systems implementation plan is a critical first step. We can offer consulting to complete this for you or provide our ISO 13485 expert help to partner with you on this planning process.
Our experience with QMS planning and implementation can be a major benefit and reduce the risks of missing a major element
The Planning Kit available for download from our Store is designed for medical device manufacturing and support businesses that need to start the implementation of their medical device manufacturing QMS
Document Templates to Facilitate Fast-Track Implementation
Creating documents for a medical device qms that meet the ISO 13485 requirements can be a major time-consuming activity and can take many months to complete. It is a very important foundational part of the quality management system, controlling the quality and safety of your medical device as well as meeting regulatory requirements. Our consulting can manage this for you, and fast-track implementation of your documentation, creation, release and training.
This is where using our document bundles created by our experienced ISO 13485 experts can provide a major role in fast-tracking your ISO 13485 implementation. We can also provide recommendations and assistance if you want to go full eQMS
Training
Providing training for employees on quality processes is a requirement of ISO 13485. We can provide Introduction training on the ISO 13485 Standard to the companies management and key employees, as well individual SOP training. This can include, design and development, risk management, supplier approval, CAPA, document control and others as required.
Coaching using our QMS experience and expertise can also be ongoing throughout the implementation process
The Folloing Training is offered through our partnership program.
Auditing
Conducting internal audits during the QMS implementation process as new procedures get released is important to ensure full compliance, and make any corrections if issues are found. Our ISO 13485 experts are trained experienced Internal Auditors and can conduct these audits for you as well as coach your staff to be handle audits in the future.
A full QMS audit is also key to conduct before the schedule Certification audits to ensure readiness and reduce risk of time delays.
Consulting Services
Focus in on the areas of your quality management system that need the help to complete your implementation and achieve certification.
Certification
ISO 13485 Certification is not a single event but is multi step process that can take may months. To stay on a fast-track plan and be best prepared for certification, our ISO experts can provide consulting and coaching to ensure success the first time.
This can include recommendations for the selection of globally recognized Certification bodies, as well as training for your team on how to prepare and act during the certification audits. Also we can help with any preparation and any corrective actions as a result of these audits.