The video provided below explains what is included when you purchase our standard operating procedures (SOPs) for ISO 13485:2016.
Do you need Standard Operating Procedures?
Our turnkey quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard and 21 CFR 820, 21 CFR 803, and 21 CFR 806 for the FDA. It also includes procedures for Canadian Medical Device Licensing and European CE Marking. In total, we have 46+ procedures (listed below). The standard operating procedures (SOPs) also have associated forms, logs, and templates. We also completed updates to our procedures for Regulation (EU) 2017/745.
If your company is only interested in compliance with the US Market (i.e., 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 830 for the FDA), we offer a turnkey quality system for the US-only market at a reduced price of $6,000. The US-only turnkey quality system does not include the seven procedures identified below as “Global”. There are additional pricing options and configurations of the turnkey quality system described at the end of the work instruction that you can view when you click on the button below. However, please remember that “turnkey” does not mean “work-free“. It takes approximately 100-120 hours to implement a medical device quality system and after you implement the quality system it will take at least 4-8 hours per week to maintain the quality system for even the smallest start-up with most processes outsourced.
In addition to procedures, forms, log sheets, and templates, the quality management system includes an initial draft of your new quality. These documents require customization to fit your operations, such as the identification of your company name and logo. The Medical Device Academy logo and [Company Name] are included within the documents as placeholders. We also provide 16 pre-recorded training webinars. We also provide exams (i.e., 10-question quizzes) to verify training effectiveness. If you submit the completed exams to us by email in the native MS Word format, we will correct the exams and email you a training certificate with your corrected exams. The list of training webinars included with our turn-key quality system is provided below:
- Good Documentation Practices
- Design Controls
- Risk Management
- How to qualify your suppliers
- Control of Nonconforming Product
- How to create a risk-based CAPA process
- 21 CFR 820
- Process Validation
- Management Review
- Complaint Handling and Vigilance
- How to audit using the process approach webinar
- Software Validation
- Create an ISO 13485 Quality Plan
- What is ISO 13485? – Stage 1 & 2 training webinars
- Design Change Webinar (Updated for 2022)
Finally, you will receive up to 8 hours of consultation to discuss any questions or assist with adjustments and edits for your individual system and situation delivered through email, phone, or Zoom Meetings.
If you are thinking about purchasing standard operating procedures (SOPs), instead of writing procedures yourself, it’s essential to understand the intent of the author that wrote the procedures. Many buyers expect to “pay by the pound.” After writing hundreds of procedures, I found that it requires more work to write a short and effective procedure than a 50-page dust collector.
If a company has a sophisticated quality management system, procedures tend to be lengthy, because each time an auditor finds a problem, another section is added to “clarify” the procedure. I try to write standard operating procedures that are concise and meet the requirements for an early-stage medical device company. Larger companies do not ask me to write many procedures. They ask me to audit procedures and to edit their procedures, but they seldom want me to start from scratch.
When Medical Device Academy writes standard operating procedures, we use a standard template for the sections. Almost everyone does this, but our template contains three unique elements:
- monitoring and measurement requirements for the process
- training and retraining requirements for personnel
- application of risk management
The video below is describing our new work instruction for how to implement the turnkey quality system. You can download the work instruction using the button above. The work instruction is specific to the Medical Device Academy team, but anyone may copy the content of this work instruction and adapt it to their quality system implementation needs. If you want a quote for the quality system, please contact Lindsey Walker directly at email@example.com.
There is a section of the work instruction that is specific to creating a project in Asana. The above video shows you how to copy the 15 steps of the quality system implementation from the work instruction into a spreadsheet. Then this is saved as a .csv file (download link). Finally, the video shows you how to import the .csv file into Asana so that you can create a project in Asana for tracking and managing the implementation of Medical Device Academy’s turnkey quality system. The video was specifically designed for the free version of Asana if you need to share the project in Asana with people outside of your organization or you do not have the budget for Asana’s paid version.
If you want to learn more about our procedure template, please read our blog about it. You can also search our blog archives for the term “SOP” or “procedure.” Other product highlights are provided below, and the button below gives you a complete list of all our procedures, forms, templates, and logs.
- Written specifically for early-stage medical device companies
- Create a ready-made off-the-shelf Quality System for your company
- Includes free updates for the ISO 13485:2016 as they become available
- Can be used for FDA 483 responses
- Are audit-ready
- Incorporates risk management into each procedure
- Includes monitoring and measurement requirements for the process
- Includes training and retraining requirements for personnel
- Written by highly experienced industry subject matter experts
If you want to purchase individual procedures or review what is included in a specific procedure, you can click on any of the hyperlinks provided below. If there is not a hyperlink, we will have one soon, or we can review the content with you in a Zoom session.
Each month Alysha picks a new procedure or webinar that will be eligible for the “Alysha” 50% discount. Just type Alysha in the discount code box. February’s discounted procedure is SYS-033, Receiving Inspection.
- POL-001 Quality Manual
- WI-002 Remote Auditing Work Instruction
- WI-003 Electronic Submission Gateway Work Instruction
- WI-007 Cybersecurity Work Instruction
- WI-009 Conducting FDA Inspections
- SYS-001 Document Control (Webinar Bundle)
- SYS-002 Control of Records
- SYS-003 Management Review (free example with webinar)
- SYS-004 Training Procedure
- SYS-005 Facility, Plant and Equipment Maintenance
- SYS-006 Change Control
- SYS-007 Customer Related Processes
- SYS-008 Design Controls
- SYS-009 Clinical Procedure
- SYS-010 Risk Management
- SYS-011 Supplier Quality Management
- SYS-012 Production Process Controls
- SYS-013 Servicing
- SYS-014 Process Validation
- SYS-015 Packaging, Handling, Storage, Shipping & Distribution
- SYS-016 Calibration
- SYS-017 Monitoring, Measuring & Analysis
- SYS-018 Customer Feedback & Compliant Handling (Webinar Bundle)
- SYS-019 Post-Market Surveillance
- SYS-020 Recalls & Advisory Notices
- SYS-021 Quality Audits
- SYS-022 Statistical Techniques
- SYS-023 Nonconforming Product (Webinar Bundle)
- SYS-024 CAPA
- SYS-025 Technical Documentation – Global
- SYS-026 Installation
- SYS-027 Purchasing
- SYS-029 Medical Device Reporting (Webinar Bundle)
- SYS-030 Labeling Procedure
- SYS-031 EO Sterilization Validation
- SYS-032 Identification & Traceability
- SYS-033 Receiving Inspection (Webinar Bundle)
- SYS-034 Monitoring of Controlled Environments
- SYS-035 Incident Reporting – Global
- SYS-036 Vigilance Reporting – Global
- SYS-037 Implant Card Procedure
- SYS-038 Controlled Environment Gowning
- SYS-039 UDI Procedure
- SYS-040 Controlled Environment Cleaning
- SYS-041 Clinical Evaluation Procedure – Global (Webinar Bundle)
- SYS-042 Canadian Licensing Procedure – Global
- SYS-043 Steam Sterilization Validation Procedure
- SYS-044 Software Development and Validation Procedure
- SYS-045 Returned Materials Authorization Procedure
- SYS-046 Packaging Validation Procedure
- SYS-047 GAMMA Sterilization Validation Procedure
- SYS-048 Usability Procedure (Webinar Bundle)
- SYS-049 Communication with competent authorities, notified bodies and other economic operators – Global
- SYS-051 Software Tool Validation Procedure
- SYS-052 Translation Procedure – Global
- SYS-053 Medical Device File Procedure (Webinar Bundle)
- SYS-054 VHP Sterilization Validation (Webinar Bundle)