Quality System Requirements for the Start-up Medical Device Company
A medical device company, small or large, MUST have a quality system, it is the law (21 CFR 820). SBME has helped many start-ups put in a quality system with a phased approach that allows both the documentation and financial burden of a quality system to be implemented over time, as needed. SBME has over a decade of experience hosting the quality system for a variety of start-up medical device companies. The “trick” to making this work effectively is to implement components of the quality system on an as-needed basis. For example, when you are pre-FDA clearance, you probably do not need a Recall Procedure but you absolutely need Design Control and Risk Management. Once you are in commercial distribution, you will need the entire system, but this phased approach allows you to be compliant even in the time prior to commercial distribution.
SBME starts with our quality system procedures that have been tested through the years via FDA and notified body audits. We are experts in a lean approach to quality system requirements that provides a robust framework to assess risk and ensure product compliance with applicable laws, regulations and standards without being overly burdensome for a small company. Using SBME’s experienced quality and regulatory expertise, a small company can be compliant with the regulations in a very cost-effective way.
There are two popular ways clients engage with the SBME quality support team:
1.?????SBME hosts your quality system: If SBME is hosting your quality system, when it is time to register with FDA, we are your registered address and FDA comes to our facility to audit. Prior to an inspection, SBME serves as your outsourced quality department to ensure the quality system is executed on a daily basis in a compliant way. During an audit, the SBME team works seamlessly with the client to address FDA’s inspection questions. This approach requires a great working relationship with open lines of communication and, in my experience, is less expensive than what you would pay for 1 - 2 experienced, full-time staff to do the same job.
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2.?????SBME provides on-demand support: SBME helps your team implement compliant procedures and then provides support on an as-needed basis to ensure the quality system is being properly maintained. In this case, SBME can provide support in an audit but it would be atypical for SBME to be the lead auditee in this scenario. SBME becomes your highly competent temporary staff for as much or as little as you need.
If you are developing a medical device, you need a quality system. Partnering with SBME will allow you to maximize your resources and still maintain compliance. Unlike other options, once you get to the point of wanting to be fully responsible for your quality system, SBME will help you transition from our support to being fully responsible yourself. With SBME, the system belongs to you, the procedures belong to you, the records belong to you. If you want to make the transition to in-house maintenance, once the transition is made, there are no other reoccurring fees from SBME. SBME will be your partner when you need support and will be your biggest cheerleader when you become self-sufficient.
If you have questions, use the link below to schedule a 30-minute call with SBME's quality experts to discuss the options.