Consultant
- NA
- 5 Case for Consiliso Books
- Unlimited Document Downloads
- Annual Document Updates & Reg Changes
- 4 hrs/yr Audit support for docs
- 1 Hard Copy and Online Consiliso Textbook
- Laws, Regulations, Guidance and Standards Database
- 30% Consulting Discount up to 8 hrs
- Over 80 Consiliso Process, Procedures and Forms available for download
- Access to Consiliso-configured Oracle Agile PLM
- X
- X
Company
- NA
- 10 Case for Consiliso Books
- Unlimited Document Downloads
- Annual Document Updates & Reg Changes
- 4 hrs/yr Audit support for docs
- 2 Hard Copy and Online Consiliso Textbook
- Laws, Regulations, Guidance and Standards Database
- 30% Consulting Discount up to 24 hrs
- Over 80 Consiliso Process, Procedures and Forms available for download
- Access to Consiliso-configured Oracle Agile PLM
- X
- X
Certification
- One Time $5,000 +T/E
- 10 Case for Consiliso Books
- Unlimited Document Downloads
- Annual Document Updates & Reg Changes
- NA (You’ll know how)
- 2 Hard Copy and Online Consiliso Textbook
- Laws, Regulations, Guidance and Standards Database
- 30% Consulting Discount up to 16 hrs
- Over 80 Consiliso Process, Procedures and Forms available for download
- Access to Consiliso-configured Oracle Agile PLM
- In-Person Training
- Certification Testing
Expand each section to learn more about each valuable offering from Consiliso’s Blueprint Subscription Services.
The medical device industry’s requirements change with every new law passed, regulation finalized, guidance document or standard released. And while the textbook is the culmination of decades of research and real-world experience, you didn’t expect us to stop continuously improving it, did you?
We don’t want to wait on information for the next edition of the hard cover book; you need the best we can offer as soon as we determine it meets our requirements for inclusion in Consiliso, the world-class standard for all medical device companies.
Yes, you can order a hard copy of the textbook (here) but your subscription gives you our latest and greatest thinking on all topics, as well as updated business process flows and data/information organizational schemes.
Most medical device makers quickly grasp the concept of design requirements–what attributes and features your product must have to be safe, effective, and compete with other solutions to a specific health issue. Knowing and keeping track of all the requirements to successfully run your business is a somewhat similar process; however, the laws and regulations of your geography (both where you build and where you sell) are your requirements in this sense. Guidance documents clarify the laws and regulations to assist companies in the implementation of those requirements. Not all requirements are specific to medical device companies; rules on safety, controlling environmental hazards, and proper financial reporting apply across most industries.
You could spend a significant amount of time on various governmental body websites to find and download the requirements that apply to your business. Or, you could use the Laws, Regulations, Guidance and Standards (LRGS) Database to quickly search and obtain up-to-date links or direct downloads. These documents are all FREE to download from the Blueprint subscription zone of this website.
Examples of laws, regulations and guidance documents include the following:
- 93/42/EEC European Medical Device Directive MDD 93/42/EEC (as amended)
- 21 CFR 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, FDA Regulation
- 29 CFR 1901-1990 OSHA
- 21 CFR 50 Protection of Human Subjects
- MEDDEV 2.5.2 REC2 Report of Design Changes and Changes to the QS
- G95-1 Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices 05/1995
- UAE-001 UAE: Medical Device Registration Guidelines for the United Arab Emirates
Using standards saves your company an enormous amount of time and effort. We’ve seen many engineers invent or duplicate test methods and schemes that exist for free or at low cost. Even if you decide to use a test method that’s not a recognized standard, you still must justify your deviation from the norm; this means having the standard on-hand and understanding its requirements.
You could spend a significant amount of time on various organization websites to find and download the standards that apply to your business. Or, you could use the Laws, Regulations, Guidance and Standards (LRGS) Database to quickly search and obtain up-to-date links to service providers that can deliver electronic versions. Most standards are not free; the cost supports the development and maintenance of the standard.
Four types of standards exist: business requirements, product requirements, test methods and reference standards.
Business Requirements Standards:
You need to know the requirements for all businesses (not just medical device manufacture), general requirements for medical device makers, and medical device Quality System-specific standards. Examples include:
- CMII-100G CMII Standard for Integrated Process Excellence and Configuration Management
- ISO 15489-1:2001 Information and Documentation Records Management Part 1: General
- MIL-HDBK-61A Military Handbook: Configuration Management Guidance
- ISO 31000:2009 Risk management — Principles and guidelines
- EN 1441:1997 Medical Devices Risk analysis
- ISO 9001:2015 Quality Management Systems- Requirements
- IEC 61160:2005 Design review
- IEC 62304:2006 Medical device software – Software life cycle processes
Product Requirements Standards:
Product requirements are just that–the “floor you cannot fall below” specific to the type of device you make. The LRGS Database allows you to search by type of product, drastically reducing the need to wade through a wide range of standard internet searches. Many countries have their own specific product requirements, making it essential to know this information during the design phase. A small sampling of product requirements standards in the medical device industry include the following:
- AAMI EC38:2007 Medical electrical equipment – Part 2-47: Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems
- ASA S3.25:2009 Standard For an Occluded Ear Simulator
- ASTM F1378:2012 Standard Specification for Shoulder Prostheses
- ASTM F2211:2004 Standard Classification for Tissue Engineered Medical Products (TEMPs)
- YYT 0313 China: Package, Label, Transport and Storage for Medical Polymer Products
- EN 12006-2:2009 Non Active Surgical Implants Particular Requirements for Cardiac & Vascular Implants
- IEC 60417:2002 Graphical symbols for use on equipment
- IEC 60601-1-12:2014 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
- IEEE 11073-10101:2004 Health informatics – Point-of-care medical devices communication – Part 10101: Nomenclature
- IPC-A-610C Acceptability for Electronic Assemblies
Test Method or Scheme Standards:
We hear from engineers that it takes just too much time to find the right test method for their situation. Some engineers have no idea that test methods required for their device exist. Providing your engineers with a searchable database through the LRGS saves a great deal of time and money. A small sampling of the test methods available for free or purchase (from the organization that develops and maintains them) includes:
- AAMI PC69:2007 Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
- AOAC 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Disinfectants Method I
- ASA S3.45:2009 American National Standard Procedures for Testing Basic Vestibular Function
- ASTM D1505:2010 Standard Test Method for Density of Plastics by the Density-Gradient Technique
- ASTM E606:2005 Standard Practice for Strain-Controlled Fatigue Testing
- ASTM F2391:2005 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
- GBT 16886.1 China: Biological Evaluation and Testing
- CLSI EP25:A Evaluation of Stability of In Vitro Diagnostic Reagents
- IEC 60601-1:2005Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (3rd Edition)
- ISO 10993-09:2009 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
- USP 36-NF31<87DC>:2013 Biological Reactivity Test In Vitro — Direct Contact Test
- USP 36-NF34:2016 Biological Indicator for Ethylene Oxide Sterilization Paper Carrier
- USP 36-NF34<881>:2016 Tensile Strength
Test Method or Scheme Standards:
Instead of everyone creating a set of agreed-upon references, use standard reference documents to save time, money, or the potential for variation in results based on different references used for similar purposes. Adoption of references like the industry-recognized ones below go a long way to ensuring everyone is aware of basic requirements. Again, there’s variation among countries and regions. A small sampling of the reference documents available in the LRGS database include:
- ASME Y14.100:2004 Engineering Drawing Practices
- ASME Y14.5M:2004 Dimensioning and Tolerancing
- ASQ Z1.4:2008 Sampling Procedures and Tables for Inspection by Attributes
- ASTM E29:2006 Practice for Using Significant Digits in Test Data
- GBT 191 China: Packaging – Pictorial Marking for Handling of Goods
- CLSI EP21:A Estimation of Total Analytical Error for Clinical Laboratory Methods
- EN 1041:2008 Information Supplied by Manufacturer with Medical Devices
- EN 980:2008 Symbols for Use in Labeling of Medical Devices
- IEC 60812:2006 Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA)
Wouldn’t it be great to just download the policy and process documents you need to implement Consiliso, in the original Word format so you can tweak them for your company? And even better, to get your hands on the original Visio diagram files, allowing you to quickly modify them to represent the specifics of your business process? Well, you can, even without a subscription, through our Consiliso Store.
However, with your subscription you can get started on your documentation needs for FREE. We will let you know when the document templates and diagrams change in response to regulatory or best practice updates.
Want to see how a Consiliso-configured information tool implements the principles and practices defined in Consiliso: The Blueprint? We’re working on a a partnership that will allow us to provide subscriber-only access to Oracle’s Agile Product Lifecycle Management (PLM) tool, loaded up with the configuration and data we’ve refined over the years.
You’ll be able to see exactly how things like Change Orders (COs), CAPAs, customer complaints, audits, supplier management, SOX controls, managing the Design History File (DHF) and regulatory submissions works as described in the textbook. We’ll even let you know when we improve or add processes and standard metadata sets to the configuration.
If you really, really like it, you will be able purchase the entire configuration. Turn on what you need as you grow. This flexibility is why we chose Oracle’s Agile PLM as our preferred tool. Other tools will work, however. You’ll just need to spend more time configuring them (or worse, creating custom code) to mimic the inherent capability of what you’ll see in the Consiliso Agile PLM environment.
NOTE: We have found that cloud-based PLM applications do not yet have all the capabilities required for a full implementation of Consiliso. Agile PLM does have a great internet and smartphone interface, and we’ve found the entire system (when properly installed and maintained by you or a 3rd party provider) to be incredibly stable. Our configuration is, therefore, not for cloud-based products.
We’ve developed a course of study to ensure you have mastered all the main principles and best practices outlined in “Consiliso: The Blueprint for Integrating Business Processes in Medical Device Companies.” We’ll also give you many real-world examples and the opportunity to get hands-on in a Consiliso-configured PLM system. You will become an expert in Consiliso business process theory. The certification includes special training videos, one-on-one instruction, and the ability to shadow an on-site Consiliso assessment at your company or another firm (T&E not included). The certification exam is unique–it’s an oral exam, and you are observed and coached by our founder, Mark Rutkiewicz, as you conduct a company assessment.