Quality and Regulatory

Over 35 years delivering quality within the complex regulatory environment.

Quality Culture

Lives depend on our products

Lives depend on our products — that’s why we are committed to achieving the highest possible standards of quality in everything we do. Every policy and process in our operations across the globe is designed and continuously monitored for full FDA and international compliance.

At Seisa, quality comes first in decision making and in every step of the design, development and manufacturing of our medical devices.

We are saving lives with our products. Therefore, we are committed to achieving the highest standards in product creation and offer consistent quality at every stage of the product lifecycle. Our cleanrooms and Seisa manufacturing facilities meet regulatory compliance.

Knowing that quality is essential to medical devices, we rely on the expertise of our team and conduct rigorous training to ensure that products are made with care and precision.

We are committed to providing medical devices that save lives every time while complying with regulatory authorities. As a result, Seisa is a key player in the medical device outsourcing market and offers medical device OEMs.


Quality Policy

Seisa’s Commitment

Seisa fulfills our commitment to providing products that meet customer expectations by maintaining our quality management system (QMS) and complying with regulatory requirements.

Seisa Quality Management System

Our Seisa QMS covers every step of the product lifecycle, from product development to high volume manufacturing of medical devices. Our QMS offers best in class services and solutions while meeting customer expectations and the regulatory requirements for medical devices.

Our documented quality system includes detailed procedures for the design, risk management, quality management (metrics and complaints), manufacturing, packaging and distribution of medical devices. We strongly focus on key steps of the regulatory process, including document control, training, and audit and CAPA management (corrective actions and preventive actions).

Seisa processes are fully compliant with the U.S. FDA’s Quality System Regulations (QSR) under regulation number 21 CFR Part 820. All of our sites are also registered and audited by the Food and Drug Administration and certified by the ISO 13485:2016 Standard.

Our QMS offers full control and monitoring of regulatory requirements for different types of medical devices depending on the classification. Regardless if the device is Class I, Class II or Class III, Seisa delivers with full FDA and international regulatory compliance.

Medical Device Registration

Seisa offers medical device registration, 510K regulatory submission and related services, regulatory reporting and vigilance. Our experts work directly with FDA and international authorities for regulatory approval of our medical devices.

Regulatory Compliance

Experience Matters

With over 35 years of experience with FDA and international regulations and audits, Seisa has a thorough understanding of the complex regulatory environment. From concept to validation and commercial release, our team designs and builds with medical device manufacturing compliance in mind. We have been delivering Class III and PMA devices for over 15 years and our global facilities are all ISO-13485 certified.

Our regulatory compliance standards include:

  • ISO 13485:2016 certified
  • Class I, II and III devices, including premarket approval (PMA)
  • FDA registered and compliant with the Code of Federal Regulations part 820
  • ISO 7 and 8 — certified cleanroom-controlled environments
  • In-house metrology labs

Download SEISA's ISO Certificate