EXPERTISE

Medical Device Startup Success

Resources for Startups

medical device startup iconMedical device startups face a myriad of challenges and quality system or regulatory roadblocks shouldn’t be among them.

Our team has more than 20 years of experience helping startups get safe and effective medical devices to market in a timely manner.

We provide guidance to medical device startups in the following areas:

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Supplier Qualification

Most startups are outsourcing a substantial portion, if not all, of their production processes to contract manufacturers to make, assemble, package, and sometimes deliver their product.

Keeping in mind a goal of efficient, high-quality components or devices delivered to the customer, your company must perform due diligence for potential suppliers early in the product development life cycle.

We have access to a vast network of ISO 13485 and ISO 9001 certified contract manufacturers with whom our clients have worked and we are pleased to make introductions as you begin sourcing suppliers. Our consultants can advise on and conduct supplier qualification efforts from initial outreach through supplier audits.

Design Controls

Since 1997, the FDA has required medical device manufacturers to follow design control requirements as stated in 21 CFR §820.30 for the design and development of devices marketed in the US.

Design controls are an integral part of making a medical device starting from the design plan through design transfer validation. If done well, design controls can protect patients and users by identifying problems in the development cycle and preventing a product redesign or potential recall downstream.

Design control requirements apply to FDA Class II and Class III medical devices, as well as a small number of low risk Class I Devices. In Canada and the European Union, medical devices must comply with the ISO 13485 design control requirements. Read our design control series for more information.

Although design controls for any device must be regimented and extensive, we have developed a simple and sensible design control process that utilizes templates and forms that a startup organization with limited stakeholders can implement.

Once established, our project managers can collaborate with you as little, or as much as you like, in implementing design controls. We can help author your design control deliverables or serve as independent reviewer along the way.

Design and Development Planning

You can’t build much of anything without a well thought out plan. Particularly a complex medical device. Whether you’re developing a robot, a catheter, or a heart valve, each product needs a design plan that can be maintained as a living document.

Our consultants have developed many design plans and will work closely with your teams to ensure your design and development goals are clearly articulated and that compliance requirements are included. We work with you to develop a backbone document to define the goals, objectives, interfaces, responsibilities and schedules.

We can be your quality and regulatory team members to ensure your product development goes smoothly and reacts nimbly to required changes. Our well-versed consultants have worked many years in design and development for companies of various sizes which allows us to also be the independent reviewer for your design reviews.

Risk Management

How does a medical device manufacturer know they have covered their bases so they will market a safe product with minimal risk? No company wants to cause patient harm or harm to the user or environment.

All devices are associated with some level of risk, however we will work with you to systematically identify and mitigate the impact of potential hazards to determine the associated risk priorities and develop an ISO 14971 compliant risk-benefit profile based upon your risk tolerance.

Whether you need help with the mechanics of a failure mode effect analysis (FMEA) or someone to work with you throughout the entire risk management process, our team has the experience to help.

Risk Planning

Identifying hazards and associated risks are imperative to prevent patient or user harm as well as preventable user errors. A key goal to ensure that a medical device is safe is to determine up-front during pre- and post-market activities the risk management activities that are needed throughout the product life-cycle — including post-market actions.

This leads to the development of a risk-benefit profile, conducted in the form of a Risk Plan, which is required by ISO 14971.

We have experts in risk planning that can walk your company through the process and customize a Risk Plan commensurate with the needs of your product.

Documentation Controls

Many types of documents must be generated to run a medical device company. Everything from design planning through customer complaints must be documented.

What benefit are the documents if you don’t know which one to use? A simple documentation mistake can create a minor mishap which may then lead to product delay or even a recall. An efficient document control system helps all other processes operate without a hitch.

QA Consulting can serve as your outsourced document department for:

  • Manual or electronic management systems
  • Document control training
  • Electronic document management system validation
  • Guidance on electronic records and signatures required by 21 CFR Part 11

Design Transfer and Process Validation

Process validation occurs during Design Transfer as the design moves from development to production. It’s critical to determine that the process is robust, that the output of the product is consistent, and that the inputs and outputs are known.

Furthermore, it must be determined that all processes efficiently produce outputs that are reliably achieved. Validation of processes such as cleaning, sterilization and custom test methods are our specialty.

Our experience with validation protocols, testing requirements and associated reports are exceptional as is our ability to troubleshoot problems that may arise.

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