Speed To Market, Inc. (STM) offers a complete Quality Management System (QMS) for medical device companies that want to get a head start on quality and regulatory compliance. The STM QMS is compliant with all major market regulations and Standards for the United States (US), European Union (EU) and Canada.
Why start generating Standard Operating Procedures from scratch when you can start with a STM QMS that has been time-tested since 2001? The STM QMS gets you up and running fast, and supports QMS certification faster than an internally written system!
Each QMS is compliant with the current versions of:
- 21 CFR §820, Quality system regulation;
- Other regulations as deemed necessary by 21 CFR §820 and/or your product.
Medical Device Directive (MDD) version
- 93/42/EEC, MDD, as amended
In Vitro Diagnostic Directive (IVDD) version
- 98/79/EC, IVDD as amended;
Both EU versions include compliance with:
- ISO 13485: 2003, Medical devices – Quality management systems – Requirements for regulatory purposes
- ISO 9001: 2000, Quality management systems – Requirements (optional, not required for medical device companies);
- IEC 62304: 2006, Medical device software – Software life cycle processes;
- SOR/98-282, Canadian medical device regulations, Sections 1 – 97 and Schedules 1 – 3, as amended
The STM QMS includes:
Procedures, Forms and Other Documents
- all the standard operating procedures (SOPs) and forms necessary for compliance with the above regulations and Standards.
- examples of complete forms for reference.
- a current list of necessary external documents and copies of each (unless protected by copyright laws).
- electronic copies of training materials, and hardcopy training manuals.
- STM’s proprietary SpeedTrac™ Document Management System (DMS) which supports 21 CFR §11, Electronic records; electronic signatures compliance.
On- and Off-Site Implementation Services
- On-site QMS tailoring to fit your organizational structure and needs, company size, and product types.
- Off-site support to answer your questions and address your concerns.
- Guidance on applicable Standards and FDA guidance documents for your product types.
- Six (6) months of phone support after your ISO 13485 certification audit.
Training for your Employees
- Your STM Account Manager will train all of your employees.
ISO 13485 Certification Audit Attendance
- Your STM Account Manager will attend the final certification audit with you to ensure your success.
STM ISO 13485 Certification Guaranteed
- STM guarantees that you will receive ISO 13485 certification!
Our success rate is 100% for all clients who have completed their ISO 13485 certification audit.
Contact STM to obtain more information about our STM QMS!