Berglund Law Office | Grace Consulting LLC | Richfield Minnesota

Grace Consulting, llc

are you an executive in the medical device industry?

It is essential to make regulatory compliance one of your highest priorities. In addition to producing quality products and making sure there is a solid market for your products, you must establish and maintain a solid compliance strategy from the outset. The obstacles and requirements  mandated by the highly regulated world of medical devices may seem insurmountable. But GRACE Consulting can help you navigate the ever-changing waters of compliance and regulation.

GRACE Consulting, LLC is your full-service regulatory consultant with the experience and attitude to help your company build, launch and sell successful products.

Mission

Medical device industry executives need to make regulatory compliance one of their highest priorities. In addition to producing quality products and making sure there is a solid market for their products, it is critically important to establish and maintain a solid compliance strategy from the outset. The obstacles and requirements mandated by highly regulated medical device sector are challenging. My mission with GRACE Consulting, LLC is to help clients affordably navigate the ever-changing waters of compliance and regulation. With many years of successful consulting in the industry, including FDA 510(k) and Health Canada submissions, ETL product certifications, and quality system assistance, GRACE Consulting, LLC provides full-service regulatory consulting with the experience and attitude necessary to help device companies design, produce, build, launch and sell successful, compliant products.

specializing in medical device, regulations, and compliance

EXPERIENCED AND SUCCESSFUL TRACK RECORD IN THE FOLLOWING AREAS:

  • Product Certification
  • Regulatory (i.e., FDA, Health Canada)
  • Quality Assurance
  • Compliance
  • Quality Management Systems
  • Product Marketing (Labeling, Ad Review, etc.)
  • Product and Establishment
  • Registration

Product certification

UL and ETL are both what are called Nationally Recognized Testing Laboratories (NRTL). NRTLs are in place to provide independent safety and quality certifications on products. Electrical appliances typically require their certification (especially 240V appliances). Some manufacturers sell unlisted products; it is very important to check for the UL or ETL mark before purchasing.

Product certification

UL and ETL are both what are called Nationally Recognized Testing Laboratories (NRTL). NRTLs are in place to provide independent safety and quality certifications on products. Electrical appliances typically require their certification (especially 240V appliances). Some manufacturers sell unlisted products; it is very important to check for the UL or ETL mark before purchasing.

UL develops the testing standards and tests to them. ETL tests to UL standards. In order for an inspector to sign off on a permitted installation for an EVSE, the National Electric Code requires the EVSE be NRTL listed.

does use both laboratories; the selection of which laboratory depends on which company provides the best value for their service that we can then pass on to our customers.

GRACE Consulting, LLC Can Help You

Design your product & quality system to ensure success

Regulatory Submissions

 GRACE has many years of experience with regulatory submissions including FDA 510(k) submissions and Health Canada Device License applications.

Quality Assurance

GRACE can assist you with the required medical device testing, certification and audits necessary for achieving a global reach if desired.

Compliance

GRACE can guide your compliance strategy and help you establish proper systems and documentation in accordance with the pertinent laws, regulations and rules relating to implementation of quality systems, sales, marketing and clinical research necessary to get to market.

Quality Management Systems

GRACE can help you develop a regulatory plan and establish proper system and documentation development, process optimization and automation, audit resolutions, and audit coordination.

Product Marketing and Promotional Ad Review

We provide advice on proper labeling, advertising and promotion of FDA-regulated products including assistance with operation manuals, device labels, and packaging.

Product and Establishment Registration

GRACE can help you register your establishment and your devices to enable you to get started with your submissions and regulatory strategies.

Assistance Locating a Manufacturer, Notified Body or European Representative

GRACE has numerous international contacts and can be helpful to anyone looking for a suitable manufacturer, notified body or authorized European representative.

Ronald Berglund has extensive experience in the medical device industry and has represented a number of importers, manufacturers, and others in compliance and regulatory matters.

Our clients have chosen to participate in one of the world’s most highly-regulated business sectors so they are entitled to experienced and knowledgeable representation. We provide advice from the establishment of a quality management system to all stages of the product life cycle from initial design, testing, manufacturing  and regulatory submission, sales and marketing.

Ronald Berglund has extensive experience in the medical device industry and has represented a number of importers, manufacturers, and others in compliance and regulatory matters.

Our clients have chosen to participate in one of the world’s most highly-regulated business sectors so they are entitled to experienced and knowledgeable representation. We provide advice from the establishment of a quality management system to all stages of the product life cycle from initial design, testing, manufacturing  and regulatory submission, sales and marketing.