An effective and affordable
Quality Management System
that establishes your commitment
to medical device regulatory compliance.
Contact us to find out how we can help you achieve ISO 13485 certification.
Medical devices are highly regulated products. Regulations apply not only to the sale and distribution of these products, but also to their design, development and manufacture. Early implementation of a robust QMS is one of the best investments a medical device company can make – especially when considering the costs of failing a certification audit.
QMS-in-a-Box can help you ensure regulatory compliance via process control, design control, retention of records, accountability, traceability and more. All for fraction of the time and cost of building your own QMS.
Need help customizing your QMS-in-a-Box? We’ve got you covered! With our successful track record of acquiring FDA, Health Canada and EU regulatory approvals, we can help you navigate the regulations correctly and shorten your time to market.
QMS-in-a-Box has been used in a wide range of applications and can be adapted to meet the needs of your products, markets and business practices. StarFish can help you customize your QMS-in-a-Box, then train and support you to the point of passing your ISO 13485 certification audit.
Customization and support services include:
We can work your management team to determine regulatory strategies for your markets of interest. Early commitment to QMS excellence from your management team is critical to getting a sound QMS implementation in place well in advance of your ISO 13485 inspection.
We can help you prepare your quality policy manual, create detailed work instructions, and customize templates and forms that increase efficiency, paving the way to ISO 13485 and FDA compliance.
StarFish Medical subject matter experts are available to provide onsite or online training in the each of the procedures and work instructions detailed in your customized QMS.
A StarFish Quality Control expert can perform a "dry run" audit prior to your certification audit. We can also review records to verify implementation of QMS procedures and to identify opportunities to streamline processes and improve customer satisfaction.
We can provide additional support for your management team during the preparation and ISO inspection phases through to your successful certification.
StarFish Regulatory Affairs experts can help in preparing your technical file and regulatory submissions.
StarFish Medical is a leading service provider in the medical device industry. We have partnered with many innovative companies to create breakthrough products for numerous medical specialty areas.
Unlike many QMS consultants, we actually work with a QMS on a daily basis (either our own or a client’s QMS). Our QMS-in-a-Box procedures come from practical, hands-on experience developing medical devices and are optimized with ease of maintenance in mind.
Our Quality Assurance and Regulatory Affairs staff are co-located with our industrial designers, electrical and mechanical engineers, physicists, software/firmware programmers and manufacturing specialists. When you work with StarFish, you have access to the knowledge and experience of our entire team of subject matter experts.
StarFish and its employees demonstrate a thorough understanding of how to lead, guide, or advise on innovative engineering projects, while applying sound Quality Management System practices to all aspects of a project, regardless of size and scope. They manage their team and assist your team ensuring sound engineering and project management principals are followed, while avoiding unnecessary paperwork and bureaucracy.
Nathan Ayoubi, B.Sc., MCPM
Product Manager
Rostrum Medical Innovations Inc.
