Regulatory & Quality
Our team of professionals are passionate about Quality – that’s why it’s in our name. We understand that lives are at stake, which is why we meticulously adhere to your quality requirements along with all medical device standards and regulations.
We employ a robust QMS with electronic storage, change tracking of records and provide DMR and DHR. We are responsive and intentional in regard to issues affecting the medical device industry such as RoHS, REACH, conflict minerals and CSR.
Certifications & Accreditations
FDA Registered: 3003477135 & 3014596751
ISO 13485 Certificate – Medical devices – Quality management systems – Requirements for regulatory purposes.
ISO 11607 Compliant
J-PMDA Compliant
Japan Manufacturing Site Accreditation – Certified Foreign Medical Device Manufacturer, pursuant to Article 13-3 of the Pharmaceutical Affairs Act.
MedAccred Certificate – Sterile Device Packaging – Assembly and Closure/Sealing of Packaging Systems.
Compliant Standards
FDA CFR 21 Part 820 – Quality System Regulation – Medical Devices
ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 11607-1 – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
ISO 11607-2 – Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14971 – Medical devices – Application of risk management to medical devices
ISO 14698 – Cleanrooms and associated controlled environments – Biocontamination control
ISO 14644-1 – Cleanrooms and associated controlled environments, Certified ISO Class 7 Cleanrooms
J-PMDA – J-PMDA MHLW Ministerial Ordinance No. 169
Licenses
State of Minnesota Board of Pharmacy Manufacturers License
Procedural Guidelines
Sterilization
AAMI ST72
Bacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing
AAMI TIR16
Process development and performance qualification for ethylene oxide sterilization – Microbiological aspects
AAMI TIR28
Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR 33
Sterilization of health care products – Radiation sterilization – Substantiation of a selected sterilization dose – Method VDmax
ISO 10993-7
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ISO 11135-1
Sterilization of health care products – Ethylene oxide – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1
Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-2
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
ISO 11137-3
Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects
ISO 11138-1
Sterilization of health care products – Biological indicators – Part 1: General requirements
ISO 11138-2
Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11737-1
Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
ISO 11737-2
Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 17665-1
Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Packaging
ASTM D3078-02
Standard Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D4169-09
Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F88-09
Standard Test Method for Seal Strength of Flexible Barriers Materials
ASTM F1140-07
Standard Test Method for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
ASTM F1608-00
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
ASTM F1886-09
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
ASTM F1929-98
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-07
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2096-04
Standard Test Method for Detecting Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
DuPont Medical Packaging
Technical Reference Guide
DuPont Tyvek® Compliance
Compliance to ISO 11607-1:2006, K-16972
ISO 11607-1
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
ISO 11607-2
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
ISTA 3A
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Quality Systems
AAMI TIR36
Validation of software for regulated processes
ANSI Z1.9 (ASQC)
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
ANSI Z1.4 (ASQC)
Sampling Procedures and Tables for Inspection by Attributes
FDA 21 CFR 210 and 211
cGMP Practice in Manufacturing, Processing, Packing or Holding of Drugs; Practice for Finished Pharmaceuticals, 4/1/2009
FDA 21 CFR 820
Quality System Regulation (GMP for Medical Devices)
ISO 13485
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 14971
Medical devices – Application of risk management to medical devices
ISO 9001
Quality management systems – Requirements
J-PMDA
J-PMDA MHLW Ministerial Ordinance No. 169
OSHA 29 CFR 1910
Blood borne Pathogens
Cleaning / Passivation
ASTM A380-06
Standard Practice for Cleaning, Descaling, and Passsivation of Stainless Steel Parts, Equipment, and Systems
ASTM A967-05
Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
ASTM B600-91
Standard Guide for Descaling and Cleaning Titanium Alloy Surfaces
ASTM F2459-05
Standard Test Method for Extracting Residue from Metallic Medical components and Quantifying via Gravimetric analysis
ISO 10993-5
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
Labeling
FDA 21 CFR Part 801
Medical Devices: Labeling, including Unique Device Identification (UDI)
ISO 15223-1 (formerly EN980)
Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements
GS1 and HIBCC
UDI Compliant Barcoding
Environmental
ISO 14644-1
Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness
ISO 14644-2
Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14698-2
Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
