Ensuring safety and meeting regulatory standards are pivotal in the rapidly evolving landscape of product development and manufacturing. For Global Validity, the Medical Equipment Compliance Associates (MECA) stands as a trusted ally, offering unparalleled expertise and comprehensive solutions in compliance and safety assurance.
At MECA, safety expertise is at the core of their mission. They strive to guide their customers efficiently through the compliance process, leveraging their expertise to minimize surprises, swiftly resolve issues, and streamline procedures. More than just service providers, MECA aims to establish enduring partnerships with their clientele, fostering relationships built on trust and collaboration.
An Industry Leader in Setting New Compliance Benchmarks
Established by Brian Biersach on July 16, 2002, MECA stands as an ISO 17025 accredited business, specializing in assisting medical device and laboratory equipment companies in achieving certification. Their primary focus revolves around the stringent IEC 60601-1, IEC 60601-1-2, and IEC 61010-1 series of standards.
Notably, MECA operates as a Certified Body Testing Laboratory (CBTL) under the IECEE CB Scheme and actively participates in prestigious programs like the UL Data Acceptance Program (DAP) and TUV Rhineland NA Partner Testing Laboratory Program (PTL), with plans to join Eurofins (MET) acceptance program soon. Moreover, MECA plays a pivotal role in the standards development process, contributing as technical experts in IEC and AAMI standards development committees. Their engineers are actively involved in shaping global standards through their engagement with IEC, ISO, AAMI, and IECEE.
Excellence in Testing and Documentation Services
MECA’s comprehensive services are tailored to offer high-quality testing and documentation necessary to demonstrate compliance with medical and laboratory equipment standards. Emphasizing the critical IEC 60601-1 and IEC 61010-1 series of standards, MECA recently expanded its services to include EMA and Wireless Global Access Services. This expansion showcases their commitment to adapting and meeting evolving industry needs.
MECA’s Primary Services include:
- Preliminary Evaluation
- Compliance Services
- Limited Testing
- Preliminary Testing (Pre-Testing)
- Medical Device or Laboratory Equipment Evaluation
- Electromagnetic Compatibility (EMC) Evaluation
- Wireless Global Access
- Third Party Certification Partnerships
- Report Revisions & Alternate Construction Evaluation
- FDA ASCA Program for 510(k)
- Upgrade to Latest Standard Edition
In a landscape where compliance and safety standards evolve rapidly, MECA stands as an unwavering ally, ensuring companies like Global Validity navigate the complex regulatory terrain with confidence and efficiency. With their commitment to excellence, dedication to safety, and proactive approach in service provision, MECA continues to be a cornerstone in driving quality and compliance within the industry.
To learn more about MECA and their services, visit their website or visit their socials.