Safety and Security

fermata does not treat women's health as "something special."

That is why we believe safety and security are "prerequisites" that should be upheld as a matter of course, rather than being specially emphasized.

For a long time, the field of women's health has been characterized by a lack of information, misunderstandings, and excessive marketing.

We aim to change this situation.

About Our Quality Control System

Handling of Medical Devices and Quasi-drugs

For products we handle that fall under the categories of medical devices and quasi-drugs, we comply with the requirements of Japan's Pharmaceuticals and Medical Devices Act (PMD Act).

  • ●Confirmation of marketing authorization
  • ●Confirmation of manufacturing registration
  • ●Confirmation of notifications, certifications, and approvals
  • ●Compliance with labeling and advertising regulations

Regulations are a system to protect consumers. fermata considers this a prerequisite.

Our Approach to GQP (Good Quality Practice)

In ensuring the quality of medical devices and quasi-drugs, we emphasize the principles of GQP (Good Quality Practice).

  • ●Confirmation of product specifications
  • ●Understanding of manufacturing processes
  • ●Collection of quality information
  • ●Confirmation of lot management

We don't simply "sell" products; we bring them to market with a full understanding of the quality flow.

Our Approach to GVP (Good Vigilance Practice)

Even after product sales, we collect user feedback and information on defects, and collaborate with manufacturers as needed.

  • ●Establishment of a complaint handling system
  • ●Collection of safety information
  • ●Appropriate feedback

Safety should be maintained continuously, not just before sales, but also after sales.

About Cosmetics and General Merchandise Products

For cosmetics and general merchandise products, we also ensure:

  • ●Confirmation of ingredient information
  • ●Confirmation of safety data
  • ●Confirmation of manufacturing system

Especially in the Women's Health domain, we value "not being ambiguous."

Medical Supervision Policy

fermata prioritizes accuracy and integrity in disseminating information related to women's health.

About Our Supervision System

When necessary, we incorporate the expertise of appropriate specialists, such as doctors, midwives, nurses, and public health professionals.

However, not all products are guaranteed to have medical effects.

We Do Not Use Exaggerated Language

  • ●Definitive statements such as "definitely cures"
  • ●Display of efficacy and effects that deviate from regulations
  • ●Emphasized expressions without scientific basis

We believe that "conveying information correctly" is the greatest foundation of trust.

Bridging Self-care and Medical Care

Much of Women's Health lies between self-care and medical care.

  • ●Avoid excessive medicalization
  • ●Do not incite anxiety
  • ●Encourage medical consultation when necessary

We consistently uphold this position.

Respect for Scientific Evidence and Legal Regulations

For the products we handle, we verify:

  • ●Safety of ingredients
  • ●Validity from medical and public health perspectives
  • ●Domestic and international regulatory status
  • ●Manufacturing system

We do not choose products simply because they are "trendy." Women's Health is a health domain rooted in daily life.

Minimizing Physical Burden

For products that come into direct contact with the body, such as intimate care products, absorbent underwear, and pelvic floor muscle devices, we prioritize:

  • ●Hypoallergenicity
  • ●Material safety
  • ●Comfort during prolonged use

There's a difference between being "usable" and being "sustainable." We value the latter.

Data Privacy Policy

Women's health data is one of the most sensitive types of personal information.

As a FemTech business, fermata places the highest priority on privacy protection.

Information We Collect

  • ●Purchase history
  • ●Inquiry content
  • ●Survey responses
  • ●Event participation information

When collecting medical or health information, we clearly state the purpose and limit it to the minimum necessary.

Third-Party Provision

We do not provide information to third parties without the individual's consent. Except where required by law, we strictly manage this information.

Safety Management System

  • ●Access restrictions
  • ●Appointment of a data management officer
  • ●Regular reviews

We believe that data is not an asset, but trust itself.

Special Considerations for FemTech

Information related to fertility, menstruation, menopause, and sexuality is directly linked to an individual's dignity.

We do not treat such information as marketing material. Our responsibility is to maintain an environment where people can consult with peace of mind.

Finally

Safety and security are not a checklist.

・●Understanding the system
・●Respecting science
・●Avoiding exaggeration
・●Not underestimating women's bodies

It is the accumulation of these actions.

fermata does not compartmentalize women's health as "something special," but rather arranges it in a way that allows women to confidently address it as an extension of their daily lives.

That is what we consider "safety and security."