Medical Device Manufacturing: What to Expect as a Make Waves White Label Partner

At CC Wellness, we are passionate about our mission to deliver personal care and intimate wellness products through science-based innovation, world-class manufacturing processes, and socially responsible practices. With every white label formula, our partners are making an impact on the well-being of their consumers around the globe.

If you’re considering CC Wellness white label products, here’s a general overview of what you can expect during the discovery and onboarding process with the Make Waves Team.

Step 1: Complete New Partner Questionnaire

You can find our questionnaire here. After submitting the form, you’ll be contacted by a Make Waves team member.

Step 2: Review Our Capabilities and Guidelines

In the introductory email from our Make Waves team, you’ll receive an overview of our company’s capabilities and basic guidelines for white label partners.

Step 3: Discuss Business Goals with Dedicated Make Waves Representative

If your team is comfortable with our guidelines and see that our services meet your requirements, a dedicated account representative will arrange a call to better understand your business, sales channels, goals, and more.

Step 4: Select Premium Componentry and Formulas

After the call, the next step is selecting premium componentry through our proprietary componentry design center. You’ll also receive tangible samples of the componentry you’re interested in purchasing.

Step 5: Approve Pricing

Once componentry and formulas have been selected, you’ll receive pricing information to approve.

Step 6: Create Packaging Artwork

After pricing is approved, your team will share label and packaging artwork with your white label account representative. They will review the artwork to make sure it meets all regulatory and quality requirements.

Step 7: Initiate Purchase Order

Once a purchase order is initiated, the white label team at CC Wellness will purchase labels, componentry and add your project to our production schedule.

Our seamless discovery and onboarding process sets our clients up for success and fuels their team with the knowledge to effectively launch white label products within their company.

Why should you consider Make Waves White Label?

Our Make Waves Team is dual ISO and FDA certified. We are an award-winning recipient of the Inc. Regionals and Stevie Awards, and our team offers exceptional service with individualized one-on-one contact to answer any questions throughout the process. Our experience with international markets can support clients with global expansion through regulatory guidance and compliance consultations.

We are 510(K) Licensed

The importance of 510(k) licensing extends beyond the manufacturing process and holds significant relevance in white label partnerships within the personal lubricant industry. In such partnerships, 510(k) licensing plays a crucial role:

  1. It ensures regulatory compliance, as the white label partner can rely on the clearance obtained by the original manufacturer, reducing the burden of regulatory hurdles.
  2. It helps mitigate risks and ensures product quality by leveraging the rigorous evaluation process that the original device underwent. This gives confidence to both the white label partner and end-users regarding the safety and effectiveness of the device.
  3. 510(k) clearance streamlines the time-to-market for white label partners, as they can avoid the lengthy and costly process of conducting clinical trials and seeking separate regulatory approval.

White Label Partnerships

When considering a white label partnership in medical device manufacturing, several factors should be carefully evaluated to ensure a successful and reliable collaboration.

  1. The white label partner should possess extensive experience and expertise in personal lubricants as well as other medical device manufacturing. This includes a solid understanding of manufacturing processes, quality control, and adherence to regulatory standards.
  2. A track record of successful 510(k) submissions is a strong indicator of the partner’s ability to navigate the regulatory landscape effectively. This will directly impact on the marketability and compliance of products like personal lubricants.
  3. Their quality management systems and commitment to compliance should be thoroughly evaluated to ensure that the devices meet the required standards.
  4. Effective communication and collaboration are essential for a successful partnership, as open lines of communication facilitate a transparent and productive working relationship.

Medical Device Manufacturing with CC Wellness

As leaders in FDA 510(k) innovation, every aspect of our work meets the highest pharmaceutical standards. Our values reflect that passion for quality; they ensure your products meet superior performance standards and maintain consumer well-being with every decision made. Work with our Make Waves team today to get all these advantages – and more.

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