Saferlife Quality Team can help you understand and apply management and quality system requirements while ensuring that your program proceeds smoothly. Our consultants will create a custom Quality Management System that is structured around your business, not the ISO 13485 standard. We provide a guaranteed, comprehensive, fixed-rate program.

The key to a successful program is understanding how much of what you do needs to be documented. We offer three different consulting programs to suit organization size, complexity and needs:

ISO 13485 Required

The ISO 13485 Standard requires certain procedures and records have to be documented as mandatory. We can assist you develop a system that meets these minimum requirements. This is particularly good for small organizations, those that are operationally straightforward and those whose processes are well understood and followed.

Partial System

In addition to the procedures and records that the ISO 13485 Standard requires we would assist you document processes that can have the greatest impact on increasing revenue or reducing costs. This is appropriate for organizations that are a little larger and are experiencing some difficulty with consistency of practices leading to errors (process non-conformances).

Full System

We would assist you document all of your processes. This is most appropriate for complex organizations experiencing issues with consistency of practices and errors (process non-conformances) in many different areas and where operational processes are not well defined or understood costing the company significant amounts of time and money.

We offer three different levels of ISO 13485 consulting support to meet your resource and time constraints:

Technical Writer 

In this role we would be responsible for writing all of your documents with input from your processes owners and handing off responsibility for the documented ISO 13485 system prior to implementation. This option is attractive to smaller organizations and those with limited resources. 

Project Management

As the project manager, we would drive the process, this includes monitoring and guiding documentation and implementation activities against the implementation plan, coordinating with all of your people and being responsible for achieving ISO 13485 registration on time and to budget.    

Support and Mentor

In this role we would support your Management Representative/ISO Coordinator as they manage your team and drive the process, offering ISO 13485 consulting support as needed and determined by this person.

Hundreds of organizations have already used our consulting guidance to design, develop and deploy cost-effective, profit-enhancing management systems. 

To understand the program stages that need to be complete prior to certification, please refer to our ISO 13485 Consulting Roadmap

Beyond registration

We can help by performing your ISO 13485 Internal Audits and performing your ISO 13485 System Maintenance.

Not Happy with your ISO Program ? 

Wish you'd come to us first?  well it's not too late! 

We offer a full suite of ISO 13485 Process Improvement and Redesign consulting services for a 'fresh start'.