This pack contains Audit-ready standard operating procedures & Quality Manuals for ISO 13485 certification to adhere with FDA & Health Canada Medical Device Regulations.
 
What is ISO:13485?
ISO 13485 specifies requirements for a Quality Management System for organizations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory requirements.
 
Benefits of ISO 13485 certification
 
Whether you are looking to operate in Canada, US or expand Internationally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Businesses with this certification communicate a commitment to quality to both customers and regulators. It is the most accepted global standard of its kind and will bring your business a host of benefits, including:
 
Full ISO 13485 compliance – which is fast becoming a prerequisite for regulatory authorities everywhere
Be confident that your company has a quality system that meets the demands of legislation in every corner of the global market
ISO 13485 will establish robust development, manufacture, distribution and control processes
The standard will help to optimize efficiency and minimize costs
ISO 13485 will also help you to monitor your supply chain so that you are always in control
 
How can MedTech Guys help to acquire ISO 13485 certification and pass MDSAP Audit?
 
Our experienced team of in-house consultants can plan and guide you through this process smoothly, covering critical areas for your company, as follows, to ensure you are well-established.
 
Identify the appropriate standard that applies to your company.
Identify scope of your QMS, set up appropriate processes and documents.
Ensure Design and Development work is thorough.
Ensure comprehensive coverage of Production and Manufacturing activities.
Ensure that Distribution channels, while extensive, are well-managed.
 
Our ISO 13485:2016 Documentation Toolkit
 
We offer ISO 13485:2016 Documentation Toolkit, which is a set of ready-to-use templates designed as per general version of standard requirements. Our readymade ISO 13485 documents includes the following:
 
ISO 13485 Quality Manual 
ISO 13485 Standard Operating Procedures 
- Control of Documents
- Control of Records
- Medical Device File
- Good Documentation Practice
- Management Review
- Technical Documentation
- Competency and Training
- Maintenance of Infrastructure
- Maintenance of Work Environment
- Design and Development
- Software Design and Development
- Software Release and Maintenance
- Software Configuration Management
- Clinical Evaluation (Non-IVD)
- Performance Evaluation (IVDs)
- Change Control
- Risk Management
- Supplier Management
- Purchasing
- Inventory Control
- Production Planning
- Production Control
- Qualification, Verification and Validation
- Product Release
- Traceability and Identification
- Sales Procedure
- Installation Procedure
- Servicing Procedure
- Analysis of Data
- Feedback and Complaint Management
- Post-Market Surveillance
- Adverse Event Reporting
- Field Safety Corrective Action (FSCA) Reporting
- Product Recall
- Audit Programme
- Nonconformity Handling
- Corrective Action and Preventive Action
Forms / Templates 
ISO 13485 Audit Checklist (more than 900 questions)
Work Instructions
 
Our turn-key quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard. These documents require customization to fit your operations, such as the identification of your company name and logo.
 
The users can implement ISO 13485 themselves, as all they need is given in our ISO 13485 documents toolkits. Our toolkit and other resources are developed by our team of regulatory experts. The key feature of using such readymade ISO 13485 documents is that they save time and cost in the process of documentation, and hence, ISO 13485 certification.
 
Why choose MedTech Guys for your ISO 13485 certification?
 
MedTech Guys specializes in medical device regulatory compliance.
Our consultants have assisted medical device companies worldwide with QMS compliance to ISO 13485 and MDSAP.
Our documentation toolkit complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.
In addition to ISO 13485 consulting, we can assist with medical device licenses and establishment licensing in Canada & US.