You don’t need a full QMS: Leverage your development partner and contract manufacturer



In today’s competitive and fast-paced market, efficiency and lean operations are essential. For startups and small businesses, setting up a full-fledged Quality Management System (QMS) can be an overwhelming endeavor in terms of cost, time, and resources. However, the good news is that you don’t always need to. By leveraging your development partner and contract manufacturer, you can streamline quality without the overhead of a full QMS. Let’s delve into how.

Understanding the QMS Landscape

At its core, a QMS is an organized framework that outlines the processes, procedures, and responsibilities needed to achieve and uphold a company’s quality goals. It’s designed to synergize a company’s operations to not only meet customer and regulatory requirements but also to drive ongoing improvements in quality and efficiency. While traditional approaches to a QMS might paint a picture of a comprehensive, intricate system, the modern landscape is evolving. With the rise of partnerships and collaborative business models, companies now have more flexible options. They can integrate established systems from experienced partners rather than constructing an entire infrastructure from the ground up.

The Power of Partnership 

Startups and smaller enterprises can sidestep the complexities of a full QMS by forging strong partnerships with the right development partners and contract manufacturers.  Here’s why:

  • Share Resources and Knowledge: Established development partners and contract manufacturers often already have a robust QMS in place and commonly their QMS is certified to meet applicable standards and requirements.  By collaborating with them, startups can tap into these resources, avoiding the redundancy of creating a system from scratch.
  • Compliance and Standards: Regulatory compliance can be a maze. By leveraging a partner with expertise in regulatory standards, businesses can ensure their products meet required guidelines without the need to invest in internal training and infrastructure.
  • Continuous Improvement: Seasoned development partners and contract manufacturers bring with them years of experience and iterative improvements. This allows startups to benefit from best practices and process optimizations right from the start.

Selecting the Right Partner

Of course, the efficiency of this approach hinges on choosing the right partner. Here are some factors to consider:

  • Reputation and References: Ensure that the chosen partner has a solid reputation in the industry and positive feedback from previous collaborations. 
  • Alignment of Values: Both parties should share a common vision and values, especially concerning quality, communication, and customer satisfaction.
  • Flexibility: As needs change, it’s essential to have a partner willing to adapt and adjust to support evolving business requirements.

Maintaining a Hybrid Approach

For some businesses, a blend of internal processes with the resources of an external partner can be the best approach. This hybrid strategy is gaining traction because it allows companies to maintain some autonomy by retaining elements of a QMS in-house, while relying on the expertise and infrastructure of a development partner for more complex components. This can be especially pertinent for unique processes or trade secrets that differentiate a business in the market. Additionally, the experience and proven methodologies of a development partner can significantly accelerate implementation of refined processes. Moreover, this symbiotic relationship often leads to the cross-pollination of best practices, fostering innovation and continuous improvement, a key component of a successful quality management system. 


While having a comprehensive QMS can be a hallmark of mature businesses, it’s not always the best or most efficient route for all, especially for small startups and smaller enterprises.  Leveraging strengths and resources of development partners and contact manufacturers can be a strategic move. It offers the dual benefit of maintaining high quality without the daunting investment. As with all business decisions, the key lies in selecting the right partners and continuously monitoring and refining the collaborative approach to quality management. 

For tailored advice and expertise on quality management solutions, contact Bold Type and benefit from our wealth of experience to integrate quality processes into your business model. 


What’s the simplest QMS your medical device startup can implement and still be compliant?


quality level

Implementing a Quality Management System (QMS) for a medical device startup is not just an exercise in regulatory compliance; it’s a foundational step to ensure the safety, efficacy, and consistency of your product.  Startups, with their innate agility and resource constraints, face the unique challenge of needing to establish a robust QMS without the luxury of large teams or budgets.  However, there is an effective way to bridge this gap; implement only the necessary elements of a QMS in-house, while relying on the expertise and infrastructure of development and contract manufacturing partners for more complex components. This approach not only balances the need for a robust system against the constraints of a young company but also represents a simplified mechanism toward establishing a QMS that remains compliant.  Here’s a basic outline of the simplest QMS your medical device startup can implement to achieve compliance:

Quality Agreement

A quality agreement is a crucial document between you and your development or contract manufacturing partner. This document outlines the roles and responsibilities of each party concerning quality and regulatory compliance.  A well-crafted Quality Agreement helps ensure product safety, efficacy, and compliance with relevant authorities by defining the organizational roles and responsibilities for things like which QMS is used and how, audit support, change control policy, and regulatory compliance.  

Document Control

Every QMS starts with proper documentation. Ensure that you have a system in place to:

  • Create and approve documents.
  • Revise and review documents when necessary.
  • Control the distribution of documents to prevent outdated or unauthorized usage.

Quality Manual, Quality Policy, and Objectives

A Quality Manual is a formalized document that describes your company’s quality management system and outlines your approach to quality assurance and process improvement.  It acts as a roadmap for how your company produces your medical device to ensure that it meets consistent quality standards.  It also may serve to identify which elements of the ISO 13485 standard your organization is subject to versus those you outsource to your development or contact manufacturing partners.  As part of your quality manual, it will be important for you to draft a clear quality policy reflecting your commitment to compliance, safety, and efficacy.  This policy should be supported by measurable quality objectives. 

Management Review

Your QMS should incorporate regulatory management review meetings to assess the suitability, adequacy, and effectiveness of your QMS.  These reviews are intended to ensure continuous improvement and alignment with regulatory changes and should be formally documented.  

Risk Management

Medical devices must undergo risk assessment to ensure patient safety.  Implementing a simple risk management process to identify, evaluate, control, and monitor risks associated with your device throughout its lifecycle is necessary to demonstrate that your QMS incorporates a risk-based approach. 

Supplier Controls

Your QMS should ensure that any components, materials, or services used in the development or manufacturing of your product are from verified suppliers.  By qualifying your development and manufacturing partners, you may leverage their supplier evaluation, selection, and monitoring process.  This could simplify (but not remove) your supplier qualification process, saving both time and money.  


Maintaining a system for training your employees to be aware of their roles and responsibilities in the QMS is required.  Your procedure should define training requirements needed to ensure that your employees are equipped to follow procedures correctly to maintain the effectiveness of your QMS.  Training records are needed to demonstrate that employees have been properly trained to carry out their assigned tasks. 

Nonconformance and CAPA (Corrective and Preventive Action)

A process to identify, document, and address nonconformities is required.  This process should tie into your CAPA system that corrects these issues and prevents their recurrence.  

Internal Audits

Even a simple QMS requires periodic internal audits to ensure processes are followed and to identify areas for improvement.  It is important that your internal audit be conducted by someone who is not directly responsible for the area being audited.  In a small organization, this can be difficult.  But with a reasonable Supplier Control process in place, your organization should be able to identify and qualify a third-party auditing agency to conduct an independent review of your QMS. 

Feedback and Complaint Handling

Once your product has hit the market, having an established and streamlined process for collecting feedback and handling complaints is a must to ensure that customer satisfaction is maintained and to address potential safety concerns promptly.  Certain types of reported events have reporting timelines associated with them.  Understanding these requirements and having an effective process to manage these activities at the ready is the key to success in this area.  


It is essential to remember that, while the above outlines a basic QMS, “simplicity” should not compromise effectiveness or compliance.  As your startup grows, the QMS should evolve to meet your company’s changing needs.  Collaboration with experienced quality and regulatory consultants or professionals can also provide guidance tailored to your specific device and marketing, ensuring that even the simplest system is both compliant and effective. 


5 reasons FDA will refuse your 510(k) application due to cybersecurity deficiencies

Over the past decade, the FDA has steadily increased the degree of scrutiny applied to cybersecurity aspects of submissions.  From the guidance issued on this topic in 2014, followed by extensive additions on the 2018 guidance and most recently the 2022 guidance, the FDA has made it clear that cybersecurity management needs to be carefully considered within 510(k) applications.  In the latest update that has become effective as of March 29, 2023, the FDA now reserves the right to refuse your 510(k) application due to cybersecurity deficiencies under certain circumstances.

Refusal Reasons:

#1 : The application does not include an adequate plan to address post market cyber security vulnerabilities in a reasonable time.  A plan like this would include how such vulnerabilities are identified, monitored and disclosed.

#2: The application does not contain evidence that the medical device design and development has followed processes and procedures that provide reasonable assurance that the device is cyber secure.

#3: The medical device within the application does not have the means to be updated postmarket to address discovered cyber security threats.  These updates would be required either on a reasonably justified regular cycle or possibly out of cycle to address a critical vulnerability.

#4: The application does not contain an appropriate software bill of materials that includes any open source software as well as commercial software used within the medical device.

#5: The application does not comply with any additional requirements that the FDA may impose through regulation to demonstrate with reasonable assurance that the medical device is cybersecure.


Ultimately, if your medical device has software and has connectivity to the Internet, it has now become a prime target for outright refusal of a 510(k) submission for lack of adherence to the rapidly evolving FDA regulations in this area.  Driven mainly by new laws as a result of the Consolidated Appropriations Act of 2023, specifically section 3305 titled “Ensuring Cybersecurity of Medical Devices” and subsequent amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) section 524B, these new cybersecurity regulations need to be seriously considered in any 510(k) submission to avoid costly delays.

At Bold Type we have always taken cyber security concerns seriously and incorporated extensive measures to address these concerns as part of our ISO 13485 compliant processes and procedures.  We have been prepared for the inevitable and well deserved increase in 510(k) scrutiny over cybersecurity threats, fundamentally addressing such concerns in our software architectures as well as within our 510(k) submissions.  For us, cybersecurity of connected Medical devices is foundational which is why we make sure we are well positioned to comply with the evolving FDA regulations in this space.

When it comes to safeguarding your connected Medical Devices to ensure a smooth FDA submission and avoid costly mistakes, Bold Type is the team to rely on.  Contact us today.

Reference: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems UnderSection 524B of the FD&C Act, March 30, 2023


Why avoiding Q-subs (presubmissions) to FDA is a terrible idea

In the realm of medical device development, ensuring the safety, effectiveness, and regulatory compliance of products is paramount. The United States Food and Drug Administration (FDA) serves as the gatekeeper, evaluating and approving medical devices before they reach the market. One crucial step in this process is the presubmission, which allows manufacturers to seek valuable feedback and guidance from the FDA. However, there is a concerning trend among some companies who opt to bypass this essential step in an attempt to expedite their product development. In this blog, we will delve into why avoiding FDA presubmissions for medical devices is not only ill-advised but also poses significant risks to patients and businesses alike.

Patient Safety as the Foremost Priority

Medical devices directly impact the lives of patients. Without engaging in FDA presubmissions, manufacturers risk overlooking crucial safety considerations and potential risks associated with their devices. Patient safety should always be the primary concern in the development and commercialization of medical devices. By bypassing presubmissions, companies increase the likelihood of introducing devices with unaddressed safety concerns, potentially endangering patients’ well-being and undermining public trust in the medical device industry.

Ensuring Regulatory Compliance

Adhering to FDA regulations is a fundamental requirement for medical device manufacturers. Presubmissions provide a crucial opportunity for companies to seek regulatory guidance and clarification, ensuring that their devices meet the necessary standards for market approval. Skipping this step significantly heightens the risk of non-compliance, which can result in delays, costly remediation efforts, and even the rejection of a product altogether. By actively participating in presubmissions, manufacturers can address regulatory concerns early on, thereby increasing their chances of successful product development and market entry.

Accelerating Product Development

Presubmissions foster a collaborative environment between manufacturers and regulatory experts. Seeking early feedback from the FDA allows companies to identify potential roadblocks, refine their development plans, and streamline the path to market approval. Engaging in presubmissions can help accelerate product development by addressing potential issues upfront, optimizing designs, and making informed decisions based on expert insights. By avoiding this critical step, companies risk encountering unforeseen obstacles, delays, and costly iterations later in the development process.

Building Market Confidence

Successfully navigating the FDA regulatory pathway enhances market confidence and increases the likelihood of product adoption. By actively participating in presubmissions, manufacturers demonstrate their commitment to quality, safety, and regulatory compliance. This engagement instills trust among healthcare providers, patients, and investors, who rely on the FDA’s rigorous evaluation process as an assurance of a device’s reliability and efficacy. Companies that choose to forgo presubmissions may face skepticism from stakeholders, impeding market acceptance and hindering potential reimbursement efforts.


The decision to avoid FDA presubmissions for medical devices has far-reaching consequences that extend beyond short-term expediency. By recognizing the importance of this topic, we understand that patient safety, regulatory compliance, and long-term business success are at stake. Engaging in presubmissions allows manufacturers to leverage valuable regulatory guidance, identify and mitigate risks, accelerate product development, and build market confidence. Prioritizing these aspects should be the cornerstone of any responsible and successful medical device development endeavor.


How We Use 3D Printing to Develop a Better Product


3D printing has been a key technology for product prototyping for well over a decade. In the last few years, however, the quality of 3D printed parts has improved so much, that it is even playing a role in manufacturing. At the same time, cost and print time has come down so much, that you can think of a part in the morning and have a functional prototype before sunset. The ability to iterate quickly results in faster time to market and higher quality products. That’s why at Bold Type, we try to design and 3D print prototypes within the first 2-3 weeks of a project.

Here at Bold Type, we specialize in product development for connected wireless medical devices and we’re firm believers in testing as early as possible.  We use 3D printing all the time so we can get a product prototype in front of the users. That prototype is going to let us see exactly how the user is going to interact with the product, what usability challenges may exist, whether the design is appropriate for the intended use, or if there is the potential for mechanical risks.  This helps limit the number of costly mistakes that crop up later in the process or – worst case scenario – prevents the launch of a product that users just don’t feel comfortable using.

3D printing helps not only with improving the user experience, but with streamlining time to market as well. Anyone who’s taken products to volume production knows that tooling can be an expensive and time-consuming part of the process, so it’s extremely important to ensure that when you’re ready for the tooling phase, you get everything right in the first try. You need to make sure that all the parts fit together correctly, that all the different components fit together properly, that you’re not going to have some weird misalignment problem between the board and the mechanical housings or between two components in the mechanical housings.

Of course, 3D printed parts are not the only option when rapid prototyping is required. For functional prototypes that look and feel more like injection molded mass production parts, we often use cast urethane prototypes. Even then, however, 3D printed parts often function as the “master pattern”. The combination of these two technologies, allow us to prototype parts that look nearly identical to the final product in just 1-2 weeks instead of 2-4 months.

3D printing can also play a role in the regulatory strategy for medical devices. Manufacturers need to demonstrate that they are following FDA design controls requirements and following a process to mitigate risk. Usability testing is also part of developing medical devices, and the best products are a result of formative usability studies that guide the design process, and summative usability studies that validate a product meets its intended use. Performing user research early and often demonstrates to FDA that you’re serious about ensuring great usability and mitigating risks, and 3D printing helps you do that.

A more recent and exciting trend in 3D printing is actual manufacturing. For a long time, 3D printed parts have been intended for prototyping, but not production. This is primarily due to the relatively high cost at higher volumes when comparted to injection molding. A secondary limitation has been that the quality and strength of the parts is not as good as molded parts. Where 3D printing shines, however, is in its customizability. If you need to make 1,000,000 identical devices, injection molding is probably the way to go. But if your product needs to be customized for each patient, injection molding is simply not practical. In these cases, 3D printing opens the door to entirely new product concepts that are optimized for each user. The challenge in these cases will come in performing process validation on the manufacturing side, but fortunately there is now plenty of precedent, and we have partners who specialize in precisely this field.

At Bold Type, we specialize in the hardware and software components of wireless connected medical device development – housings, electronics, embedded software, mobile apps, web applications, cloud connectivity, and cybersecurity. A big part of our success is our ability to get to the user testing phase early, gathering that feedback to make sure that we design the product to fit the client need. Incorporating a key technology such as 3D printing allows us to build the right product for the client, with minimal risk and in full regulatory compliance.




Electrical Impedance Myography in Duchenne Muscular Dystrophy

I was involved in some very cool projects during my post-MIT years in Boston, working with some very smart people like Lucy Lu Wang, Seward Rutkove and Eugene Williams.

For this Technolog Thursday post – a multicenter study evaluating the effectiveness of EIM in measuring muscle pathology in Duchenne muscular dystrophy, a degenerative neuromuscular disease that occurs primarily in young males.


Edwin Armstrong’s Impact on Connected Medical Devices

My doctoral work was on the design of ultra-low power circuits and systems for medical devices.

If you’re suffering from insomnia and want to geek out on some math, here’s your chance:

During that time, I came across the work of Edwin Armstrong, who is an engineering hero of mine.

You’re probably wondering exactly who Edwin is but the funny thing is, he’s had a dramatically bigger impact in your life than you know.

Edwin Armstrong was a true genius of the 20th century. He invented wireless communications techniques and architectures that are used to this day – think frequency modulation (FM) and the superheterodyne receiver. He also invented a type of receiver called a “super-regenerative amplifier” (SRA), which is a lot less common these days.

I decided to design an SRA and went down the theoretical rabbit hole to develop a mathematical model that would explain its frequency response.

This was tricky because most systems are linear, time invariant and employ negative feedback. The SRA is nonlinear, time variant, and employs positive feedback, taking advantage of the huge amplification that happens when a system becomes unstable.

It’s fricking genius and one of the reasons I admire Armstrong so much.