Improve Product Compliance with SPK
Your team deserves guidance from consultants that have been there and done that.
A recent study showed that 53% of CEOs from global life sciences companies consider regulations to be a top disruptive trend. That disruption is seen in additional costs, time delays to get products to market, and missed opportunities. Because SPK is involved in helping get our client’s products to market, we know how to optimize processes and procedures to limit the time it takes to remain compliant, but quickly get your products to market.
We Work with Companies Big and Small. We Can Help You Too!
SPK’s team has over 20 years of expertise working with organizations that range from globally recognized brands to small, family-owned companies. Start-ups and established multinationals choose SPK as their partner to achieve and maintain compliance with global standards & regulations. This positions us to provide unique insights that you can’t find anywhere else. We can help design your processes or systems to make it easier for your company to be compliant.
Industries & Standards
Medical Device & Life Sciences
- ISO 13485:2016
- MDSAP – Med Device Single Audit Program
- US FDA 21 CFR Part 820
- US FDA 21 CFR Part 11
- European MDD / AIMDD / IVDD
- New EU MDR / AIMDR / IVDR
- Health Canada CMDR
- ISO 14971 Risk Management
- IEC 60601 Electrical Equipment
- IEC 62304
- HIPAA
Automotive
- ISO 26262-1:2018
- IATF 16949:2016
- AIAG Core Tools (APQP, PPAP, FMEA, MSA, and SPC)
- VDA
Quality Management
- ISO 9001:2015
- ISO 17025 Testing & Calibration
- ISO 17100 Translation Services
- API Spec Q1
- ISO/IEC 80079-34
- Food Safety (GFSI, BRC, SQF, IFS, FSSC/ISO 22000, 21 CFR Part 110, etc.)
Aerospace & Defense
- AS9100 Rev. D
- AS9110
- AS9120
- DO-178C
- NADCAP
- CMMC
- ITAR
GxP
- GMP (Good Manufacturing Practice)
- GLP (Good Laboratory Practice)
- GDP (Good Distribution Practice)
- GCP (Good Clinical Practice)
Software & Cybersecurity
- ISO 27001
- NIST 800-171
- SOC 2
- IEC 62443
Energy & Industrial
- ISO 50001
- IEC 61508
- OSHA Safety
What Our Clients Say
SPK has been an invaluable partner in transforming our software development process. With SPK's guidance, our team embraced efficient methodologies and cutting-edge tools, significantly improving our development cycle and product quality.
Joshua Talbert
CEO, mysherpas
Working with SPK feels like working with co-workers in my company, not like interacting with a typical technical support vendor. SPK staff are responsive and partner with me.
Jay DiToro
Director of Systems & Technology, Veranex
The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive.
Evan Bruck
Director, Active Device Research and Development, BBraun Medical Inc.
Related Compliance Resources
Ensuring Information Quality and Version Control with the Top 10 ISO 9001 Practices
Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...
Ensuring Information Quality and Version Control with the Top 10 ISO 9001 Practices
Your PLM, The Cloud, and FDA Regulation: What You Need to Know
Product designs, documentation, and processes aren’t just valuable intellectual property, they’re your license to operate. In the highly regulated medical device industry, manufacturers must carefully consider these factors. If you’re using a Product Lifecycle...