That One Signature: 7 Questions You Must Ask Before Trusting a Manufacturer with Your Menstrual Cup Brand

Your menstrual cup brand is more than just a product; it's a mission. You're ready to take off, and the market is booming.

But let’s pause for a second, because there’s a hard truth we need to talk about.

Your brand's entire future—its safety, your customers' trust, and your hard-earned reputation—all comes down to one signature: the one on your contract manufacturing agreement.

This isn't a pad or a pantyliner. A menstrual cup is an intimate, long-term medical device. Getting it wrong isn't an option.

Choosing the wrong partner can be disastrous. One misstep can poison product quality, derail your timelines, and damage your reputation before you've even launched. We're here to guide you through the 7 essential questions you need to ask.

Ask them now, before you sign, while you still have all the leverage. Once that ink is dry, it might be too late.

At Crescenzia Wellness, we believe in total transparency. We've seen too many passionate brands get burned. Before you sign anything, you need to think of your manufacturer as more than just a vendor. In many ways, they're your new co-founder.

Here are the 7 questions that will separate a true partner from a costly mistake.

1. Compliance: Are they actually certified to make medical devices?

A clean factory floor is nice, but the paperwork is what protects you. Your manufacturer must have an ISO 13485 certification. This isn't optional. It's the official global standard for quality systems in medical devices. It's your proof that they have formal systems for risk management, document control, and consistent production. Without it, you're exposed.

• Dig Deeper: Ask for their ISO 10993 (Biocompatibility) report. This is the test that proves the material is safe for long-term internal use and won't cause irritation or toxicity. If they hesitate on either of these, walk away. Period.

2. Will they let you see everything?

A good partner welcomes scrutiny. You should have the right to audit their facility—and not just a friendly walkthrough. This is a deep dive into their processes, their training, and their records. It’s how you verify their promises match their actual day-to-day operations.

• Dig Deeper: Ask them: Can you perform an unannounced audit? Can they instantly show you the batch records for the silicone they used in their last five production runs? You're looking for instant, "open-book" transparency. That's what a real partnership looks like for a high-risk device.

3. Do they really understand medical-grade silicone?

All silicone is not created equal. The difference between cheap "food-grade" and true medical-grade silicone (like USP Class VI) is massive. Using the wrong stuff risks chemical leaching, bacterial issues, bad reviews, and product failures. Your manufacturer needs to be an expert in the material's purity, hardness (its 'Shore' value), and sourcing.

• Dig Deeper: Ask them where they get their raw materials from. Do they manage the whole supply chain, or do they outsource it, adding another layer of risk you can't control?

4. Can they grow with you?

You need a partner who can handle your first 1,000 units and your first 100,000 units after you land that huge retail deal. Going from a small batch to mass production is where many manufacturers fail. They must have the tooling, staff, and systems to scale up without cutting corners on quality.

• Dig Deeper: Don't accept vague answers. Ask for data. "What's your maximum daily output right now? And what's your documented plan to double that in 90 days if we get a massive order?"

5. Are they just a factory, or are they a design partner?

Your unique design—the shape, the stem, the firmness—is what makes your brand special. A great manufacturer should be a technical partner, helping you refine your design for better performance, user comfort, and manufacturing efficiency. They should be innovators, not just order-takers.

• Dig Deeper: This one is critical: Who owns the molds and tooling? The answer must be you. Make sure your contract clearly states that all intellectual property for your custom designs belongs to your brand.

6. How will they protect your big idea?

Your design is your crown jewel. If your manufacturer also works with competitors, how do you know your idea is safe? A "leaked" design can destroy your market advantage. They must have rock-solid, documented policies (like NDAs, secure servers, and limited factory access) to protect your intellectual property.

• Dig Deeper: What specific controls, NDA protocols and physical security measures are in place to ensure your designs are not shared or replicated by their internal teams or other clients?

7. What's the real all-in cost?

Don't be fooled by a low unit price. A cheap quote often means they're cutting corners on materials, testing, or compliance—costs that will come back to bite you later in the form of delays, fines, or recalls. You need to know the Total Cost of Ownership (TCO).

• Dig Deeper: Ask for a complete breakdown. "Does this quote include all required regulatory documentation, quality testing reports for every single batch, and traceability files?" A good partner won't hide these fees. They'll give you a clear, fixed-price TCO so you can actually protect your margins.

Choosing the Right Partner Changes Everything

This is easily the biggest decision you'll make for your brand.

At Crescenzia Wellness, we welcome these tough questions. We're an open book because our entire process—from our ISO 13485-certified quality systems to our transparent audits—was built to answer them with confidence.

We don't just manufacture; we validate, certify, and protect your brand's future.

Talk about your vision with a partner who's as serious about safety and quality as you are.