We’re Built For Quality And Compliance
We invite you to join us in our systemic commitment to product quality and regulatory compliance.
HDA is certified to ISO 13485 for the design and manufacture of medical devices, and registered with the FDA and California FDB to manufacture medical devices. As a seasoned contractor in the medical device development and manufacturing space, we have spent decades meticulously establishing management procedures that streamline our ability to efficiently and effectively produce high-quality, patient-safe, industry-approved products that still fit within our customers’ vision.
At HDA, we have decades of regulatory expertise. We can respond to and anticipate regulatory needs early on in the process of developing and manufacturing your product, and help you with:
Our robust quality system allows us to provide you with world-class products throughout their life cycle. This means better designs, complete documentation and safe, effective and reliable products in the field.
We believe that our commitment to quality is crucial to your success, and continue to invest in our people and quality management system (QMS) to ensure that we deliver the best value to our clients by using well-established development, production and documentation methods.
Precision, patient safety, and reliability are paramount in medical device manufacturing. A company’s internal processes define its ability to embrace those markers, and its quality system defines its internal processes’ effectiveness and consistency.
A sound quality system can define a company’s development, manufacturing, and product lifecycle management procedures. In the medical world, where manufactured products are used to diagnose, treat, and improve quality of life, this definition becomes critical for ensuring the highest level of safety possible.
As a medical device contract manufacturer operating in low and mid-volume spaces, we understand the critical role that standards and certifications play in every sphere of the industry. Standards and certifications align with the regulatory requirements held by national and international bodies and make products safer and the processes to approve them smoother and faster.
Regulations act as a roadmap, guiding manufacturers through the necessary steps to meet compliance and reducing the risk of costly delays or product recalls. At HDA, our compliance is not simply an accessory, but built into the deeper mechanics of our company culture and process.
Providing state of the art technical expertise with old-world craftsmanship to medical startup and multinational companies worldwide, HDA is based in Orange County, California. We are proud to partner with you to take your newest ground-breaking innovation from concept to market.
