Quality & Regulatory
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Built-In Quality. Ensuring Excellence from Start to Finish.

Home MEDICAL QUALITY & REGULATORY COMPLIANCE

BONASTRE
SEAL OF QUALITY

Our through approach ensures exceptional product quality, guaranteeing attention to every technical detail and proactively anticipating and resolving issues during Production.

METROLOGY

We ensure the highest quality with advanced metrology equipment and skilled personnel. Our facilities include a 20ºC tempereature-controlled room to certify restrictive tolerances.

REGULATORY DOCUMENTATION SUPPORT

We support you throughout the regulatory process, ensuring the design and development phases result in comprehensive documentation suitable for regulatory.

CERTIFICATIONS

We are fully equiped to meet any requirements for products seeking CE marking or FDA approval. Our comprehensive Quality Management System, certified to ISO 13485, ISO 9001, UNE 166002, and ISO 14001, guarantees excellence at every step.

Our Unique Approach to Manufacturing Drawings at Bonastre

At Bonastre, we create our own manufacturing technical drawings for every part we produce. With over 60 years of experience, we have developed extensive know-how that complements and enhances original specifications. Often, design drawings lack certain specifications or contain inconsistencies from a manufacturer’s perspective. Our meticulous process, conducted alongside the client, ensures all necessary manufacturing details are addressed, resulting in accurate, high-quality, and reliable production over time.

Thorough Detailing Process

We immerse ourselves in the part itself, rigorously examining every detail that affects its manufacturing. By becoming the part, we identify and specify all necessary details to guarantee a reliable industrialized process, especially when multiple manufacturing phases are involved.

Comprehensive Specifications

Our process specifies every tiny detail, eliminating any doubt during manufacturing. Our drawings are comprehensive, allowing for precise programming and inspection of the part. We ensure that the real manufactured parts match the technical drawings by including details often overlooked, such as real morphologies that result from the actual tools used.

Holistic Manufacturing Considerations

We consider not only how the part will be produced and programmed but also how it will be inspected and packaged. This ensures that the part is correctly prepared for subsequent manufacturing phases, preventing issues that arise without thorough technical discussions before production begins. Our approach allows us to proactively anticipate and resolve potential issues during production.

Technical Features and Manufacturing Phases:

There are specific technical features that need to be taken into account to manufacture the part when other manufacturing phases are involved. Our approach ensures these features are meticulously detailed and considered.

Unmatched DFM and DFA Expertise

We apply our unparalleled Design for Manufacturing (DFM) principles and Design for Assembly (DFA) techniques, making sure that all adjustments among different parts are perfect. This comprehensive approach optimizes the design for manufacturing and guarantees the highest quality and reliability in our manufacturing processes.

Proactive Client Collaboration:

We achieve optimal results through collaboration with our clients. When specifications lack or are
inconsistent, we propose our suggestions for client validation. We engage in technical and functional
discussions to arrive at the best solutions. This collaboration ensures that all specifications are accurate and reliable. By focusing on these detailed and integrated processes, which we have perfected over six decades, Bonastre sets the standard for exceptional quality and precision in the production of medical components and parts.