Rocky Mountain Regulatory Affairs Society
Achieving RA/QA Compliance LLC
Achieving RA/QA Compliance, LLC provides a variety of regulatory and quality assurance support to start up and all sizes of businesses including, multinational medical device companies. Achieving RA/QA Compliance, LLC assists in identifying and integrating regulatory and quality assurance strategies for the growth and success of the organization and employees by balancing regulatory compliance and business needs, resulting in customer satisfaction and bottom line results.
AlloSource
www.allosource.org
AlloSource is a U.S. tissue network that processes, matches and delivers safe, superior quality allografts for patients. We have grown into one of the nations’ largest non-profit bone, soft tissue and allograft skin networks in the country and are highly regarded for our good tissue practices and commitment to constantly improving the tissue donation, processing and transplant process.
Arete Quality Consulting, LLC
www.areteqc.com
Arete Quality Consulting serves the pharmaceutical, medical device, and combination product industries, specializing in cGMP, GLP, QSR:
- Quality Assuarance / Quality Control / Design Assurance
- Analytical Method Validation / Transfer / Verification
- Audit / Review and Remediation
- Technical Writing
- Laboratory Optimization
- Training
Aytu BioScience, Inc.
Aytu BioScience is a specialty healthcare company focused on developing and commercializing novel products in the field of urology. Aytu is initially concentrating on prostate cancer, male sexual dysfunction and male infertility and plans to expand into other urological indications for which there are significant medical needs.
Borealis Compliance, LLC
www.borealiscompliance.com
Quality Systems advice and support to the medical device industry since 2003
Bridging Health Matters
www.bridginghealthmatters.com
Bridging Health-Matters (BrHM), a full service Bio-Pharmaceutical Consulting group. We pride ourselves on thinking outside the box, with the ultimate goal of saving you time and money on your road to International Health Authority Approvals. Whether you are an academic scientist with your first product ready to progress out of the laboratory or a major bio-pharmaceutical company looking for assistance during a peak performance period, BrHM has the expertise to assist you in bridging the gap.
CARE Research LLC
www.careresearchllc.com
CARE Research, LLC is a preclinical contract research organization (CRO) serving the biomedical research, pharmaceutical, and device and drug development industries.
Cavendish Scott, Inc.
www.cavendishscott.com
ISO 9001, ISO 13485, FDA QSR, MDD, CMDR (and other standards) quality management system consulting, implementation, and training
CHD Bioscience
www.chdbioscience.com
CHD Bioscience is focused on reducing healthcare-associated infections. We decrease the quantity and severity of healthcare-associated infections by killing bacteria and other pathogens through the use of our proprietary family of oxidizing molecules.
Cleanroom World
www.cleanroomworld.com
Clean Room Equipment and Clean Room Supplies for controlled environments. Concentrating all levels of clean rooms, Sterile supplies for pharmaceutical industry and non outgassing aerospace environments.
Training Center open, complete with hard-wall cleanroom for hands-on cleanroom training
Cochlear Americas
https://www.cochlear.com/intl/home
Cochlear is the leading global expert in implantable hearing solutions. For more than 30 years, Cochlear has helped over 450,000 people connect to the world of sound. With a global team of over 3,200 passionate experts, Cochlear is an organization you can be proud to work for. Our people say making a difference in the lives of others is the number one reason they enjoy working at Cochlear. With a range of solutions for different types of hearing loss, Cochlear maintains the industry’s largest investment in R&D. To improve our products and services we currently work in collaboration with over 100 research partners based in 20 countries.
Commissioning Agents
www.commissioningagents.com
Specializing in commissioning and validation, QA and regulatory support, and project management
ComplianceAcuity, Inc.
www.complianceacuity.com
ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical products industry. ComplianceAcuity excels by pairing intelligent business planning with strategic regulatory and quality systems.
Corgenix, Inc.
www.corgenix.com
Corgenix, Inc., a subsidiary of Corgenix Medical Corporation, is based in metropolitan Denver, Colorado with its international marketing office near Cambridge, England. Research, development, manufacture and marketing of the Company’s in vitro diagnostic products is performed at the Company headquarters in Broomfield, Colorado. Corgenix employs approximately 36 individuals at this facility and four in the international marketing office in Peterborough, England. The Company has strategic alliances and various agreements with several OM, OEM partners and distributors worldwide and utilizes independent sales reps in the United States to market and sell its products.
Creation Technologies
www.creationtech.com
Provider of contract medical device design and contract manufacturing
DePuy Synthes, a Johnson & Johnson Company
The DePuy Synthes Companies are part of the Johnson & Johnson Family of Companies. We offer the world’s most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
Mark Dott LLC
www.MarkDottLLC.com
Consulting for sterilization, ISO sterilizer validation (EO, steam, gamma, Sterrad, dry heat), and USP / AAMI microbiology testing.
Encision, Inc.
www.encision.com
Encision designs, develops, manufactures and markets surgical devices that allow surgeons to optimize technique and patient safety during a broad range of surgical procedures. Encision's patented active electrode monitoring technology is emerging as a standard of care in minimialy-invasive surgery.
ERI Group
ERI Group offers our clients a world-class, multidisciplinary team that spans the entire process of bringing a medical device to market—from product design, development, quality, regulatory, and contract manufacturing. With 35 years of experience and deep technical expertise to handle the most complex projects, we connect the dots so our clients don’t have to.
FDA Compliance Simplified
www.fdasimplified.com
FDA Compliance Simplified™ provides regulatory affairs services, patent & prior art evaluation; product development support, FDA & USDA labeling services to the biotechnology, pharmaceutical, cosmetic, dietary supplement & food industries.
Framework Solutions, Inc.
www.framesol.com
Framework Solutions, Inc. (FSI) works with some of the world’s largest pharmaceutical and medical device companies to offer high-quality project management and professional services specific to advertising and promotional review. FSI is the industry leader in providing process-management support focused on facilitating and executing the promotional review process. We help our clients navigate the complexities of meeting and adhering to all industry regulations while enabling them to deliver content more effectively. FSI was founded in New Milford, CT in 2000 and recently established an office in Broomfield to support the West.
GGC Medical Device Consulting
www.ggcmd-consulting.com
Design Control, Process Validation, and Design for Manufacturing customized programs to meet FDA and ISO 13485 Standards
GMP by CynJay, LLC
This company focuses on assisting small companies understand and implement GMP processes for sterility assurance. Microbiology issues are a speciality, with comprehensive understanding of facility validations, cleanrooms, USP requirements for microbiological testing and process validations.
Greffex, Inc.
www.greffex.com
Greffex is an innovative global leader in the delivery of accelerated pandemic and bio-terror vaccines using the world's first universal platform, our GreVac™ delivery system.
Our proven technology, the GreVac platform, a fully-deleted, helper-independent adenoviral vector system, delivers unprecedented time-to-market, cost efficiency and safety.
Our vibrant pipeline of vaccines, transplantation and gene therapy products continue to create value for our people, partners and investors.
Hart Partners LLC
Hart Partners specializes in working with emerging & start-up companies to provide expert Quality System & Reg Affairs strategy & advice. I can build your QS from the ground up while also assisting you with regulatory submissions and FDA interactions
IMSM, Inc.
www.IMSM.com/US
IMSM is a full-service ISO consultancy that was established in 1994 in the UK. IMSM has since grown to become an international market leader in quality, environmental, health & safety, information security and business continuity management systems.
Our IMSM accredited consultants will guide you and your organization from initial gap analysis through to certification. IMSM has assisted more than 12,000 clients to attain various ISO certification and has over 200 ISP specialists across the world to serve every ISO related need.
IMSM Service includes
• An IRCA or equivalent qualified Assessor will guide, advise and help you with all aspects of each ISO standard throughout the assessment process from start to finish
• Visits and Assessments as needed to review your present procedures and advise where amendments may be necessary to meet the standard
• Full support services throughout the process to minimize disruption to your business and reduce the workload required by the company
• Guidance and assistance in the implementation of your Procedures to ensure compliance with Standard and ongoing Continuous Improvement
• IMSM will take you to the stage where you are fully Compliant with the requirements of the Standard. A Certification body of your choosing will then complete your certification.
Deliverables are:
- A complete set of ISO Standard operating procedures manuals
- Actions, Roles and Responsibilities Training of all personal involved with the operating standards, including management awareness and responsibilities
- ISO Certification
ISO-MD Consulting
www.ISO-MD.com
ISO-MD consulting is a consulting company that specializes in Quality Management Systems and related regulatory compliance help. We do anything from create quality management systems from scratch, help if you have a specific compliance issue or update your current system. Call for a free consultation to discuss what your needs are.
Manx Consulting - Nick Bries
www.linkedin.com/nickbries
I specialize in keeping older medical evices in production, in compliance and in the field. EMC, Third Edition, RoHS, supplier issue resolution, critical components issues, obsolete parts/components and contract manufacturer relations are all in my wheelhouse. How can I help? Contact me for a free consultation regarding your specific situation.
MedDev Compliance
A full service consultancy providing start-ups and established organizations with pragmatic solutions for complex regulatory and quality system challenges.
Specializing in: Process and Software Validation | Quality System Remediation | Regulatory Submissions | New Quality System Development and Implementation | Quality Audits | Process Improvement/Optimization
B. Michael Consulting, LLC
B. Michael Consulting LLC provides industry-leading quality consulting and engineering for medical devices, IVDs, and combination products specializing in quality systems, quality assurance, post-market surveillance, remediation, project management, and software development lifecycle.
Mikron Corporation Denver
http://www.mikron.com/en/mikron-automation/
Design, manufacture, sales and service of high-performance automated assembly equipment for small parts for the medical, automotive, electrical-electronic, consumer goods, and office equipment industries.
Network Partners
Network Partners is a professional services firm that helps clients complete the work necessary to provide their products to patients. Serving the medical device, pharmaceutical and biopharmaceutical industries with core competencies of Regulatory Affairs, Packaging Engineering, Labeling, Quality and Project Management.
Osypka Medtec Inc.
Osypka Medtec is an Original Equipment Manufacturer (OEM) and is dedicated to working with medical device manufacturers and suppliers to manufacture innovative, quality product solutions or components. We provide device technology and products using the latest state-of-the-art design and manufacturing to meet the high standards of our customers. This includes producing specialty assemblies, modifications to standard products, and custom fabrication to meet the needs of product specifications. Our team is dedicated to the successful manufacturing process that is analyzed and optimized every step of the way to maximize efficiency and effectiveness in an ISO 13485 environment.
ProPharmaCon, LLC
www.propharmacon.com
ProPharmaCon offers a wide range of services that includes regulatory, promotional reviews, business development, technical writing, quality, audits, and CMC strategy. We strive to understand your specific needs to provide high quality deliverables and work to become an integral member of your organization.
Quest Product Development and Manufacturing
www.quest-corp.com
Quest is a contract product development and manufacturing company with 15 years of experience in instrumentation development. Our experience with 300+ companies has resulted in 100 medical products including IVD, vital sign monitors, and electro-cautery systems.
Rocky Mountain Orthodontics, Inc.
www.rmortho.com
Rocky Mountain Orthodontics (RMO, Inc.) is an internationally known manufacturer of orthodontic appliances headquartered in Denver, CO. We are a privately owned company and have been in business for over 75 years.
Rocky Mountain Regulatory and Quality Partners
RMRQP specializes in Regulatory Affairs consulting and Quality System creation and remediation. We help our clients make sense out of Regulatory Affairs and Quality Systems, both domestically and internationally. Our consultants are well versed in domestic and international medical device regulations, the ISO certification processes, and working with government agencies in the U.S. and abroad. Consultants have extensive experience with MDD/MDR gap assessments and remediation, ISO 13485 auditing, EU CER (per MDR) auditing and creation (i.e. literature searches and reviews, CER authoring; clinical trial monitoring and reporting), 510(k) and PMA submissions, post-market surveillance, product and process validation, design engineering, and many others. Our staff of consultants brings real world experience to the table to develop solutions in a way that makes sense for the business.
Siemens PLM Software / Polarion ALM
https://polarion.plm.automation.siemens.com/products/medical
Siemens PLM Software’s knowledge of industry standards combined with unified Application Lifecycle Management (ALM) capabilities help accelerate innovation for our medical customers, while streamlining quality assurance and automating proof of compliance.
Steinman Recruiting Associates
www.steinmanrecruiting.com
Steinman Recruiting Associates specializes in the placement of engineering and technology professionals. With nearing 30 years in the business, you can count on our team-based processes, technical know-how, and ethics. Our commitment is to provide the best service to both our candidates and the companies we serve.
The Matthews Group
An event planner with over 20 years experience specializing in technical meetings and conferences for the medical device and biotech industries. For information, contact Nan Matthews, nan@themattgrp.com
Technical Safety Services
www.techsafety.com
For nearly 50 years, Technical Safety Services, Inc. has provided unparalleled service to biotechnology, pharmaceutical, medical device, academic research and food production facilities throughout North America and around the world.
Across these and other diverse industries, TSS serves to test, certify and calibrate the critical equipment and controlled environments crucial to their operations.
With an ISO 9001 certified quality system and nationwide network of skilled technicians, Technical Safety Services is uniquely positioned to ensure your operation remains productive and in compliance with regulatory standards.
In addition to our core suite of services, TSS offers professional validation, commissioning and decommissioning to support our clients through every phase of their development.
Telos Partners, LLC.
https://www.telospartnersllc.com/
Telos Partners specializes in partnering with medical device and biotechnology companies through a tailored approach that helps these companies understand and achieve their ultimate business goals in regulatory/quality (US, EU, Canada, ROW) and evidence services (pre-clinical, clinical, and health economics).
Temple University, RA and QA Graduate Program
www.pharmacy.temple.edu/raqa
Temple U pioneered graduate education in Regulatory Affairs and Quality Assurance in 1968. With over 80 courses in RAQA, 15 certificates, and four MS programs, its programs enable students to enter or accelerate their RA career path.
TOLMAR, Inc.
www.tolmar.com
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company. TOLMAR develops and manufacturers both proprietary and generic pharmaceutical products with specific focus in therapeutic areas of dental, dermatology, and oncology. TOLMAR provides our customers with a competitive and sustainable combination of product development and commercial services. Our strengths include a proven development, clinical, regulatory and manufacturing infrastructure with highly trained and experienced staff. Several of our marketed products are still in an early stage growth mode.
Toltec Ventures
www.toltec.biz
Toltec provides medical device engineering services compliant with US FDA and international regulatory standards. We assist medical device companies with the development and maintainence of medical devices in full compliance with the regulations and standards. We have the capability to provide full R&D medical device engineering services or can supplement medical device companies’ internal needs throughout the product life-cycle.
Virtus Consulting, Inc.
http://www.linkedin.com/in/morganj
Regulatory compliance remediation; global product submission strategy and execution, due diligence preparation and assessment; quality system establishment, evaluation and certification; training in QS/RA disciplines.
VRL Laboratories
www.virden.com
With over twenty years of experience in human and animal testing, VRL Laboratories has three high complexity testing laboratories located in San Antonio, Texas; Centennial, Colorado; and Suzhou City, Jiangsu China. VRL Laboratories - Human Cell and Tissue Division's focus is performing Donor Eligibility Screening and Microbiology Testing, using the most appropriate regulated technology for the transplant and medical communities.
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Disclaimer
RMRAS does not endorse these companies and makes no representations, warranties or guarantees as to, and assumes no responsibility for, the products or services provided by these members. RMRAS expressly disclaims all liability for damages of any kind arising out of the use or performance of the products or services provided by members posted in the directory.
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